Import Alert 66-78
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 66-78
Published Date: 09/11/2023
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Drugs, Based Upon Analytic Test Results"
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 09/11/2023 updates the guidance section including agency contacts. Changes to the import alert are bracketed by asterisks (***).
The Food and Drug Administration (FDA) collects and analyzes samples of drugs, including finished dosage drug products and active pharmaceutical ingredients, considered at risk for adulteration that pose a health risk due to contamination, substandard quality, or ingredient substitution. Detention without physical examination may be appropriate when analytical test results reveal a potential health risk.
The Food and Drug Administration (FDA) collects and analyzes samples of drugs, including finished dosage drug products and active pharmaceutical ingredients, considered at risk for adulteration that pose a health risk due to contamination, substandard quality, or ingredient substitution. Detention without physical examination may be appropriate when analytical test results reveal a potential health risk.
Guidance:
Divisions may detain without physical examination (DWPE) shipments of the drugs that appear to be adulterated, listed on the Red List of this Import Alert.
NOTE: This Import Alert does not apply to contamination in drugs based on microbial test results. Please refer to Import Alert 55-05.
***Divisions should follow the guidance in the Regulatory Procedures Manual (RPM) Chapter 9-2 for Personal Importation shipments. Commercial or promotional shipments, and products subject to DWPE are generally not amenable to the use of enforcement discretion.***
Recommendations for addition to DWPE of drugs not listed on the Red List should be forwarded to ***Division of Import Operations (DIO)*** for review. Recommendations should include background information, analytical worksheets, product labeling, and entry documents. DIO will coordinate the review of the DWPE recommendation with ***CDER/OC/ODSIR/DGDDP/ICB*** for consideration.
Release of Articles Subject to Detention Without Physical Examination Under This Import Alert:
DWPE of the drugs listed on the Red List of this Import Alert remains in effect until such time as FDA is satisfied that the appearance of a violation has been removed.
In order to secure release of an individual shipment subject to DWPE under this Import Alert, the importer and/or another responsible party to the shipment should provide evidence that the shipment does not contain drugs that appear to be adulterated. ***CDER/OC/ODSIR/DGDDP/ICB*** will evaluate on a case-by-case basis.
To inform FDA's assessment of these shipments and whether the appearance of a violation has been overcome, the firm may provide documentation, including the results of third-party laboratory analyses of a representative sample, using analytical methods that provide results to demonstrate that the firm has addressed the conditions that gave rise to the appearance of a violation. As part of its evaluation of such laboratory analyses, FDA may consider whether the laboratory has been previously inspected by FDA and found to be in compliance with Current Good Manufacturing Practice (CGMP) requirements.
Removal from DWPE (REMOVE FROM RED LIST):
***To request removal of a firm's drugs from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so the Agency will have confidence that future entries will be in compliance with the Federal Food, Drug, and Cosmetic Act. This information may include, but is not limited to, a letter detailing its corrective actions, accompanied by documentation. FDA might also determine that it is appropriate to verify a firm's corrective actions through an inspection prior to the Agency considering the appearance of adulteration to be addressed.
In accordance with Chapter 9 of the Regulatory Procedures Manual (RPM), a minimum of five (5) consecutive non-violative commercial shipments may be required before the Agency can consider that the appearance of a violation has been overcome. For further guidance on removal from DWPE, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention without Physical Examination (DWPE)," available at: https://www.fda.gov/media/71776/download.***
If a firm and/or a representative thereof would like to petition for removal from DWPE under this Import Alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or, be sent via email to: Importalerts2@fda.hhs.gov
Requests for removal from DWPE will be referred by DIO to ***CDER/OC/ODSIR/DGDDP/ICB*** for evaluation.
Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov.
***Questions or issues involving compliance of imported drugs and drug products should be addressed to the CDER Imports Compliance Branch at CDERImports@fda.hhs.gov.
***
NOTE: This Import Alert does not apply to contamination in drugs based on microbial test results. Please refer to Import Alert 55-05.
***Divisions should follow the guidance in the Regulatory Procedures Manual (RPM) Chapter 9-2 for Personal Importation shipments. Commercial or promotional shipments, and products subject to DWPE are generally not amenable to the use of enforcement discretion.***
Recommendations for addition to DWPE of drugs not listed on the Red List should be forwarded to ***Division of Import Operations (DIO)*** for review. Recommendations should include background information, analytical worksheets, product labeling, and entry documents. DIO will coordinate the review of the DWPE recommendation with ***CDER/OC/ODSIR/DGDDP/ICB*** for consideration.
Release of Articles Subject to Detention Without Physical Examination Under This Import Alert:
DWPE of the drugs listed on the Red List of this Import Alert remains in effect until such time as FDA is satisfied that the appearance of a violation has been removed.
In order to secure release of an individual shipment subject to DWPE under this Import Alert, the importer and/or another responsible party to the shipment should provide evidence that the shipment does not contain drugs that appear to be adulterated. ***CDER/OC/ODSIR/DGDDP/ICB*** will evaluate on a case-by-case basis.
To inform FDA's assessment of these shipments and whether the appearance of a violation has been overcome, the firm may provide documentation, including the results of third-party laboratory analyses of a representative sample, using analytical methods that provide results to demonstrate that the firm has addressed the conditions that gave rise to the appearance of a violation. As part of its evaluation of such laboratory analyses, FDA may consider whether the laboratory has been previously inspected by FDA and found to be in compliance with Current Good Manufacturing Practice (CGMP) requirements.
Removal from DWPE (REMOVE FROM RED LIST):
***To request removal of a firm's drugs from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so the Agency will have confidence that future entries will be in compliance with the Federal Food, Drug, and Cosmetic Act. This information may include, but is not limited to, a letter detailing its corrective actions, accompanied by documentation. FDA might also determine that it is appropriate to verify a firm's corrective actions through an inspection prior to the Agency considering the appearance of adulteration to be addressed.
In accordance with Chapter 9 of the Regulatory Procedures Manual (RPM), a minimum of five (5) consecutive non-violative commercial shipments may be required before the Agency can consider that the appearance of a violation has been overcome. For further guidance on removal from DWPE, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention without Physical Examination (DWPE)," available at: https://www.fda.gov/media/71776/download.***
If a firm and/or a representative thereof would like to petition for removal from DWPE under this Import Alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or, be sent via email to: Importalerts2@fda.hhs.gov
Requests for removal from DWPE will be referred by DIO to ***CDER/OC/ODSIR/DGDDP/ICB*** for evaluation.
Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov.
***Questions or issues involving compliance of imported drugs and drug products should be addressed to the CDER Imports Compliance Branch at CDERImports@fda.hhs.gov.
***
Product Description:
Various Drugs (refer to Red List)
Charge:
For finished dosage drug products and active pharmaceutical ingredients that appear to be
adulterated due to harmful impurities:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article
appears to have been prepared, packed, or held under insanitary conditions whereby it may have been
contaminated with filth, or whereby it may have been rendered injurious to health. [Adulteration, Section
501(a)(2)(A)]
OASIS Charge Code – INSANITARY
AND/OR
For finished dosage drug products and active pharmaceutical ingredients that appear to be
adulterated due to Current Good Manufacturing Practice violations:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used
in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not
appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
[Adulteration, Section 501(a)(2)(B)]
OASIS Charge Code - DRUG GMPS
AND/OR
For finished dosage drug products and active pharmaceutical ingredients that appear to be
adulterated because its strength differs from, or its quality or purity falls below the standard set forth
in an official compendium recognized by the FD&C Act:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article
appears to be represented as a drug the name of which is recognized in an official compendium and its
strength appears to differ from or its quality or purity appear to fall below the standards set forth in
such compendium. [Adulteration, Section 501(b)].
OASIS Charge Code - DR QUALITY
AND/OR
For finished dosage drug products and active pharmaceutical ingredients whose name is not
recognized in an official compendium and that appears to be adulterated because its strength differs from,
or its quality or purity falls below, that which it purports or is represented to possess:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears
to be represented as not being recognized in an official compendium and appears its strength differs
from or its quality or purity falls below, that which it purports or is represented to possess.
[Adulteration, Section 501(c)]
OASIS Charge Code - DR QUALITC
AND/OR
For finished dosage drug products and active pharmaceutical ingredients that appear to be
adulterated because they have been mixed or packed therewith so as to reduce quality or strength:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be
a drug that a substance has been mixed or packed with so as to reduce its strength. [Adulteration,
501(d)(1)]
OASIS Charge Code – REDUCED
AND/OR
For finished dosage drug products and active pharmaceutical ingredients that appear to be
adulterated because it has been substituted wholly or in part therefore:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be
a drug that a substance has been substituted wholly or in part. [Adulteration, 501(d)(2)]
OASIS Charge Code – SUBSTITUTE
adulterated due to harmful impurities:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article
appears to have been prepared, packed, or held under insanitary conditions whereby it may have been
contaminated with filth, or whereby it may have been rendered injurious to health. [Adulteration, Section
501(a)(2)(A)]
OASIS Charge Code – INSANITARY
AND/OR
For finished dosage drug products and active pharmaceutical ingredients that appear to be
adulterated due to Current Good Manufacturing Practice violations:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used
in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not
appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
[Adulteration, Section 501(a)(2)(B)]
OASIS Charge Code - DRUG GMPS
AND/OR
For finished dosage drug products and active pharmaceutical ingredients that appear to be
adulterated because its strength differs from, or its quality or purity falls below the standard set forth
in an official compendium recognized by the FD&C Act:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article
appears to be represented as a drug the name of which is recognized in an official compendium and its
strength appears to differ from or its quality or purity appear to fall below the standards set forth in
such compendium. [Adulteration, Section 501(b)].
OASIS Charge Code - DR QUALITY
AND/OR
For finished dosage drug products and active pharmaceutical ingredients whose name is not
recognized in an official compendium and that appears to be adulterated because its strength differs from,
or its quality or purity falls below, that which it purports or is represented to possess:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears
to be represented as not being recognized in an official compendium and appears its strength differs
from or its quality or purity falls below, that which it purports or is represented to possess.
[Adulteration, Section 501(c)]
OASIS Charge Code - DR QUALITC
AND/OR
For finished dosage drug products and active pharmaceutical ingredients that appear to be
adulterated because they have been mixed or packed therewith so as to reduce quality or strength:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be
a drug that a substance has been mixed or packed with so as to reduce its strength. [Adulteration,
501(d)(1)]
OASIS Charge Code – REDUCED
AND/OR
For finished dosage drug products and active pharmaceutical ingredients that appear to be
adulterated because it has been substituted wholly or in part therefore:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be
a drug that a substance has been substituted wholly or in part. [Adulteration, 501(d)(2)]
OASIS Charge Code – SUBSTITUTE
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
CHINA
GUANGDONG KEMEI PHARMACEUTICAL TECHNOLOGY CO LTD
Date Published : 01/07/2021
3rd And 4th Floor, No 16 (#6 Plant) Jiye Rd , Nanhai
, Foshan,
Guangdong CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/07/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 01/07/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 01/07/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 01/07/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 01/07/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 01/07/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 01/07/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 01/07/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 01/07/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Guangzhou Minghui Cosmetics Co., Ltd.
Date Published : 12/21/2020
Donghua Industrial Zone, Renhe Town , 1 Dongchang Road
, Guangzhou,
Guangdong CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/21/2020
Notes: All Drugs and Drug Products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 12/21/2020
Notes: All Drugs and Drug Products
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 12/21/2020
Notes: All Drugs and Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 12/21/2020
Notes: All Drugs and Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 12/21/2020
Notes: All Drugs and Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 12/21/2020
Notes: All Drugs and Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 12/21/2020
Notes: All Drugs and Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 12/21/2020
Notes: All Drugs and Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 12/21/2020
Notes: All Drugs and Drug Products
Guangzhou Shiruoni Cosmetics Co., Ltd
Date Published : 03/10/2021
Room 307, Bldg. 6, West Zone Union Town , 12 Dagang Road
, Guangzhou,
Guangdong CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Guangzhou Yapeng Fine Chemical Co., Ltd.
Date Published : 03/10/2021
271# Haogang Big Road , Dagang Town, Nansha District
, Guangzhou,
Guangdong CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Guangzhou Youxing Cosmetic Co., Ltd
Date Published : 10/08/2020
Changhong , No. 14 Shuanghe 2nd Rd; Baiyun
, Guangzhou,
Guangdong CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 10/08/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 10/08/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 10/08/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 10/08/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 10/08/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 10/08/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 10/08/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 10/08/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 10/08/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Guangzhou Zhongkebaishi Health Industry Co., Ltd.
Date Published : 03/29/2021
High Tech Industrial Fl. , No. 1 Fengying Fourth Road; Conghua
, Guangzhou,
Guangdong CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/29/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/29/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 03/29/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 03/29/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 03/29/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 03/29/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 03/29/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 03/29/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 03/29/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Hou Fu Biotech (Jiangsu) Co., Ltd
Date Published : 12/03/2020
Building 5 South Of Floor 3
, Nantong,
Jiangsu CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/03/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 12/03/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 12/03/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 12/03/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 12/03/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 12/03/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 12/03/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 12/03/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 12/03/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Ningbo Haishu Huasen Houseware Co., Ltd
Date Published : 04/21/2022
Maimian Bridge Village, Jishigang Town , Haishu
, Ningbo,
Zhejiang CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 04/21/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 04/21/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 04/21/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 04/21/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 04/21/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 04/21/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 04/21/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 04/21/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 04/21/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Ningbo Haishu Huayu Industrial & Trade Co., Ltd.
Date Published : 04/22/2022
Jishigang Industrial Park , 288 Jishi (E) Rd., Yinzhou
, Ningbo,
Zhejiang CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 04/22/2022
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 04/22/2022
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 04/22/2022
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 04/22/2022
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 04/22/2022
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 04/22/2022
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 04/22/2022
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 04/22/2022
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 04/22/2022
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
ShangRao Chunyu Technology Co., Ltd.
Date Published : 11/06/2020
Shangrao Economic-Technical , Xuri Zone; Dev. Area
, Shangrao,
Jiangxi Province CHINA
53 - - - -- Cosmetics
Date Published: 11/06/2020
Desc: All Drugs and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 11/06/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 11/06/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 11/06/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 11/06/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 11/06/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 11/06/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 11/06/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 11/06/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 11/06/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
95 - - - -- Light Emitting Non-Device Products
Date Published: 11/06/2020
Desc: All Drugs and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
ZHEJIANG SANYUANSE COSMETIC CO L
Date Published : 04/21/2022
Add: No. 525 Jixiang Ro , Lanxi
, Jinhua,
Zhejiang CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 04/21/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 04/21/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 04/21/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 04/21/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 04/21/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 04/21/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 04/21/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 04/21/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 04/21/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
DOMINICAN REPUBLIC (THE)
Ardil Comercial S.R.L.
Date Published : 06/30/2021
Pastora Elida Km 19 No. 03, Apto. 1
, Santo Domingo Este,
Santo Domingo DOMINICAN REPUBLIC (THE)
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 06/30/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 06/30/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 06/30/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 06/30/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 06/30/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 06/30/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 06/30/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 06/30/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 06/30/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
GUATEMALA
Genesis Partnership Company SA
Date Published : 09/02/2020
Km 19.5 Carretera Al Pacifico, Bodega 28
, Villa Nueva,
Guatemala GUATEMALA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
KOREA (THE REPUBLIC OF)
AriBio H&B
Date Published : 03/04/2021
77 Hanbangekseuporo5-Gil
, Jecheon,
Chungcheongbukdo KOREA (THE REPUBLIC OF)
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 03/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 03/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 03/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 03/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 03/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 03/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 03/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
David Cosmetic
Date Published : 03/10/2022
64-17 Seokcheon-ro 453Beon-gil
, Bucheon,
Gyeonggi KOREA (THE REPUBLIC OF)
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/10/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/10/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 03/10/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 03/10/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 03/10/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 03/10/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 03/10/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 03/10/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 03/10/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
David Cosmetic Co., Ltd.
Date Published : 03/10/2022
14 Dodam8-Ro
, Seo,
INCHEON KOREA (THE REPUBLIC OF)
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/10/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/10/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 03/10/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 03/10/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 03/10/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 03/10/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 03/10/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 03/10/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 03/10/2022
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
DongBang Cosmetics Co., Ltd.
Date Published : 01/11/2021
39 Gajaeullo32beon-Gil
, Seo,
Incheon KOREA (THE REPUBLIC OF)
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 01/11/2021
Desc: All Drugs and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 01/11/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 01/11/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 01/11/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 01/11/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 01/11/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 01/11/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 01/11/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 01/11/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 01/11/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
80 M - - LR Sterilizer, Chemical
Date Published: 01/11/2021
Desc: All Drugs and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Mirfeel Korea Co., Ltd
Date Published : 03/24/2022
77 Hwanggeumro323beon-Gil , Yangchon-Eup
, Gimpo,
Gyeonggi KOREA (THE REPUBLIC OF)
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/24/2022
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/24/2022
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 03/24/2022
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 03/24/2022
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 03/24/2022
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 03/24/2022
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 03/24/2022
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 03/24/2022
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 03/24/2022
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
80 L - - RJ Disinfectant, Medical Devices
Date Published: 03/24/2022
Desc: All Drugs and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
95 R - - GI Hand Washing Sanitizer, Ultraviolet Hygiene Products, Non-Medical
Date Published: 03/24/2022
Desc: All Drugs and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
MEXICO
4E Global, S.A.P.I. de C.V.
Date Published : 07/16/2020
Av. Uno Norte No. 15 , Parque Industrial Cartagena, Tultitlan
, Tultitlan De Mariano Escobedo,
Mexico MEXICO
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 07/16/2020
Desc: All Drug and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 07/16/2020
Desc: All Drug and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/16/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/16/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
AAA Cosmetica, SA de CV
Date Published : 07/07/2020
Calle Recursos Hidraulicos 1 , Pueblo La Loma, Tlalnepantla De Baz
, Tlalnepantla,
Mexico MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/13/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/13/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 07/13/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 07/13/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 07/13/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 07/13/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 07/13/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 07/13/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 07/13/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
80 L - - RJ Disinfectant, Medical Devices
Date Published: 07/13/2020
Desc: All Drug and Drug Products
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
95 R - - GI Hand Washing Sanitizer, Ultraviolet Hygiene Products, Non-Medical
Date Published: 07/13/2020
Desc: All Drug and Drug Products
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
ABSARA COSMETICS SAPI DE CV
Date Published : 02/04/2021
Calle Acapulco 35 , Col. Roma Norte, Cuauhtemoc
, Ciudad De Mexico,
Ciudad de Mexico MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 02/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 02/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 02/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 02/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 02/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 02/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 02/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 02/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 02/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Absara Cosmetics S.A.P.I DE C.V.
Date Published : 02/04/2021
Autopista Mexico-Toluca Km 53.5., Planta Ii , Lerma
, Lerma De Villada,
Mexico MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 02/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 02/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 02/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 02/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 02/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 02/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 02/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 02/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 02/04/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Albek De Mexico S.A. De C.V.
Date Published : 08/04/2020
Oriente Cuatro No. 11 Nuevo
, San Juan Del Rio,
MEXICO
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 08/04/2020
Desc: All Drug and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/04/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/04/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/04/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/04/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/04/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/04/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/04/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/04/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/04/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Asesores en Mantenimiento Hidraulico e Industrial, S.A. de C.V.
Date Published : 09/02/2020
Avenida De La Unidad 100 , Col. Valle De Infonavit 1er. Sector, Monterrey
, Monterrey,
Nuevo Leon MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Asiaticon, SA de CV
Date Published : 08/11/2020
Conkal No. 62
, Ciudad De Mexico,
Estado de Mexico MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Botanicals Internacional S.A. de C.V.
Date Published : 08/13/2020
Ave. De La Luz No. 73 , Zona Industrial Parque Industrial La Luz, Cuautitlan Izcalli
, Cuautitlan Izcalli,
Mexico MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Broncolin, S.A. de C.V.
Date Published : 07/29/2020
Calle Sur 16 No. 353 , Col. Agricola Oriental, Iztacalco
, Ciudad De Mexico,
Ciudad de Mexico MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/29/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/29/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 07/29/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 07/29/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 07/29/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 07/29/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 07/29/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 07/29/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 07/29/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
C&G Laboratorios SA de CV
Date Published : 10/09/2020
Calle Pestalozzi No 415 , Col. Narvarte Poniente, Benito Juarez
, Ciudad De Mexico,
Ciudad de Mexico MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 10/09/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 10/09/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 10/09/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 10/09/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 10/09/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 10/09/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 10/09/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 10/09/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 10/09/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
CORPORATIVO BURELI SA DE CV
Date Published : 09/24/2020
Calle Lazaro Cardenas San Jeronimo 10 , Unidad Habitacional San Jeronimo Tepetlacalco, Tlalnepantla De Baz
, Tlalnepantla,
Mexico MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/24/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/24/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 09/24/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 09/24/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 09/24/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 09/24/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 09/24/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 09/24/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 09/24/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
DDI MULTINACIONAL SA DE CV
Date Published : 07/13/2020
Javier Espinoza Mz. 30, Lt. 20 Santa Martha Acatitla
, Iztapalapa,
MEXICO
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 07/13/2020
Desc: All Drug and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 07/13/2020
Desc: All Drug and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/13/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/13/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 07/13/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 07/13/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 07/13/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 07/13/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 07/13/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 07/13/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 07/13/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
DEPQ Internacional S. de R.L de C.V.
Date Published : 07/31/2020
Calzada De Guadalupe 2830-A , Col. El Santuario, San Luis Potosi
, San Luis Potosi,
San Luis Potosi MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/31/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/31/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 07/31/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 07/31/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 07/31/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 07/31/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 07/31/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 07/31/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 07/31/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
DIBAR NUTRICIONALS S DE RL DE CV
Date Published : 06/22/2021
Eucalipto No. 20 Col. Puerto de Buenavista
, Morelia,
Michoacan MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 06/22/2021
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 06/22/2021
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 06/22/2021
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 06/22/2021
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 06/22/2021
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 06/22/2021
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 06/22/2021
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 06/22/2021
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 06/22/2021
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
DMM Vission, S.A. de C.V.
Date Published : 09/02/2020
Calle Lago Guija 234 , Col. Agua Azul, Nezahualcoyotl
, Ciudad Nezahualcoyotl,
Mexico MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 09/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Datsen SA DE CV'
Date Published : 07/15/2020
Avenida Del Sol # 308 , Residencial Galaxias, Centro
, Villahermosa,
Tabasco MEXICO
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 07/15/2020
Desc: All Drug and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Dibar Nutricional S. de R.L. de C.V.
Date Published : 06/22/2021
Cedro No. 310 Los Angeles
, Morelia,
Michoacan MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 06/22/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 06/22/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 06/22/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 06/22/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 06/22/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 06/22/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 06/22/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 06/22/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 06/22/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Distribuidora Lagunera del Norte, SA de CV
Date Published : 03/10/2021
Av Juarez 5735-5 , Fracc. Residencial Las Torres, Torreon
, Torreon,
Coahuila de Zaragoza MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 03/10/2021
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
ESTRATEGIA HOSPITALARIA SA DE CV
Date Published : 08/14/2020
Avenida Inglaterra 2684 , Col. Vallarta, Guadalajara
, Guadalajara,
Jalisco MEXICO
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 08/14/2020
Desc: All Drug And Drug Products
Notes:
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/14/2020
Notes: All Drug And Drug Products;
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/14/2020
Notes: All Drug And Drug Products;
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/14/2020
Notes: All Drug And Drug Products;
61 - - - -- Human and Animal Drugs
Date Published: 08/14/2020
Notes: All Drug And Drug Products;
62 - - - -- Human and Animal Drugs
Date Published: 08/14/2020
Notes: All Drug And Drug Products;
63 - - - -- Human and Animal Drugs
Date Published: 08/14/2020
Notes: All Drug And Drug Products;
64 - - - -- Human and Animal Drugs
Date Published: 08/14/2020
Notes: All Drug And Drug Products;
65 - - - -- Human and Animal Drugs
Date Published: 08/14/2020
Notes: All Drug And Drug Products;
66 - - - -- Human and Animal Drugs
Date Published: 08/14/2020
Notes: All Drug And Drug Products;
Eskbiochem SA de CV
Date Published : 07/15/2020
Av. Japon Mexico No. 412 Bod. 50 Ciudad Industrial
, Celaya,
Guanajuato MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION
Date Published : 12/22/2020
Colonia Jardines de la Reina , Calle Castilla 1473a
, Tonala,
Jalisco MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/22/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 12/22/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 12/22/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 12/22/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 12/22/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 12/22/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 12/22/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 12/22/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 12/22/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
GRUPO YACANA MEXICO SAS DE CV
Date Published : 08/20/2020
Avenida Alfonso Reyes 714 , Fracc. Contry La Silla, Guadalupe
, Guadalupe,
Nuevo Leon MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
GRUPO YACANA MEXICO SAS DE CV
Date Published : 08/20/2020
Distrito B6 112
, Monterrey,
MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Grupo Asimex de Mexico SA de CV
Date Published : 08/17/2020
Mario Pani No 750 Piso 10-C , Col. Santa Fe Cuajimalpa, Cuajimalpa De Morelos
, Ciudad De Mexico,
Ciudad de Mexico MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/17/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/17/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/17/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/17/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/17/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/17/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/17/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/17/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/17/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Grupo Insoma, S.A.P.I de CV
Date Published : 07/10/2020
Avenida Antonie Lavoisier # 31
, Cuautitlan Izcalli,
Mexico MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Grupo Plast-Y-Kosas, SA de CV
Date Published : 08/11/2020
Callejon Puebla 105 , Col. Rodriguez, Reynosa
, Reynosa,
Tamaulipas MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
HARMONIC NATURE S DE RL MI
Date Published : 08/20/2020
Calle Lacandon 205 , Unidad Habitacional Azteca, Guadalupe
, Guadalupe,
Nuevo Leon MEXICO
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 08/20/2020
Desc: All Drugs and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/20/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Healthy Foods & Nutrition Lab de Mexico S.A. de C.V.
Date Published : 08/13/2020
Zona Industrial Xhala , Calle Curtidores No. 38
, Cuautitlan Izcalli,
Mexico MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Ignacio Reyes Gonzalez
Date Published : 08/21/2020
Calle Independencia 416 , Col. Los Puestos, Tlaquepaque
, Tlaquepaque,
Jalisco MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/21/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/21/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/21/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/21/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/21/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/21/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/21/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/21/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/21/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Incredible Products, SA de CV
Date Published : 08/13/2020
Calle Castellanos Y Tapia 921 , Col. Santa Maria
, Guadalajara,
Jalisco MEXICO
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 08/13/2020
Desc: All Drugs and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 08/13/2020
Desc: All Drugs and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 08/13/2020
Desc: All Drugs and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Industrias Cklass S de RL de CV
Date Published : 09/14/2020
Avenida Ignacio L. Vallarta 4030 , Col. Vallarta, Guadalajara
, Guadalajara,
Jalisco MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/14/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/14/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 09/14/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 09/14/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 09/14/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 09/14/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 09/14/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 09/14/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 09/14/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Inovaker Lab SA de CV
Date Published : 10/02/2020
Calle Luis Quintanar 105 , Col. Bella Vista, Monterrey
, Monterrey,
Nuevo Leon MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 10/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 10/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 10/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 10/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 10/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 10/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 10/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 10/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 10/02/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Ismar Soluciones Dinamicas SA de CV
Date Published : 08/14/2020
Calle Industria Del Vestido 2153 , Industrial Zapopan Norte, Zapopan
, Zapopan,
Jalisco MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/14/2020
Notes: All Drug And Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/14/2020
Notes: All Drug And Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/14/2020
Notes: All Drug And Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/14/2020
Notes: All Drug And Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/14/2020
Notes: All Drug And Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/14/2020
Notes: All Drug And Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/14/2020
Notes: All Drug And Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/14/2020
Notes: All Drug And Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/14/2020
Notes: All Drug And Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
JG Atlas Comercios, SA de CV
Date Published : 08/07/2020
Calle Trueno Paraisos Delcolli 871 , Col. Paraisos Del Colli, Zapopan
, Zapopan,
Jalisco MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/07/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/07/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/07/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/07/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/07/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/07/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/07/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/07/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/07/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
JOSE MIGUEL GUTIERREZ SALAS
Date Published : 09/01/2020
Calle Higuera 66
, Tepic,
MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/01/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/01/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 09/01/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 09/01/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 09/01/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 09/01/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 09/01/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 09/01/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 09/01/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Laavo Clean, S.A. de C.V.
Date Published : 05/09/2023
Elias Flores Sur No. 300-A , Col. Almacentro, Apodaca
, Ciudad Apodaca,
Nuevo Leon MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 05/09/2023
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within (1) the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements; and (2) the meaning of section 501(c) of the FD&C Act because the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 05/09/2023
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within (1) the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements; and (2) the meaning of section 501(c) of the FD&C Act because the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/09/2023
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within (1) the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements; and (2) the meaning of section 501(c) of the FD&C Act because the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
60 - - - -- Human and Animal Drugs
Date Published: 05/09/2023
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within (1) the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements; and (2) the meaning of section 501(c) of the FD&C Act because the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
61 - - - -- Human and Animal Drugs
Date Published: 05/09/2023
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within (1) the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements; and (2) the meaning of section 501(c) of the FD&C Act because the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
62 - - - -- Human and Animal Drugs
Date Published: 05/09/2023
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within (1) the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements; and (2) the meaning of section 501(c) of the FD&C Act because the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
63 - - - -- Human and Animal Drugs
Date Published: 05/09/2023
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within (1) the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements; and (2) the meaning of section 501(c) of the FD&C Act because the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
64 - - - -- Human and Animal Drugs
Date Published: 05/09/2023
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within (1) the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements; and (2) the meaning of section 501(c) of the FD&C Act because the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
65 - - - -- Human and Animal Drugs
Date Published: 05/09/2023
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within (1) the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements; and (2) the meaning of section 501(c) of the FD&C Act because the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
66 - - - -- Human and Animal Drugs
Date Published: 05/09/2023
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within (1) the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements; and (2) the meaning of section 501(c) of the FD&C Act because the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
Laboratorios Jaloma S.A. de C.V.
Date Published : 08/03/2020
Calle Aquiles Serdan No. 438 , Col. Oblatos, Guadalajara
, Guadalajara,
Jalisco MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/03/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/03/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/03/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/03/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/03/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/03/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/03/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/03/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/03/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Limpo Quimicos, SA de CV
Date Published : 07/15/2020
Jose Silvestre Aramberri No. 149
, Escobedo,
Nuevo Leon MEXICO
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 07/15/2020
Desc: All Drug and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Liq-E S.A. De C.V.
Date Published : 07/15/2020
Calle Puerto Tampico 345 , Col. La Fe, San Nicolas De Los Garzageorgia
, San Nicolas De Los Garza,
Nuevo Leon MEXICO
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 07/15/2020
Desc: All Drug and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
MXL Comercial, SA de CV
Date Published : 07/24/2020
Calle Cromo No 206 , Col. Industrial Del Norte, Leon
, Leon De Los Aldama,
Guanajuato MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/24/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/24/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
60 - - - -- Human and Animal Drugs
Date Published: 07/24/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 07/24/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 07/24/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 07/24/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 07/24/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 07/24/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 07/24/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
MYM Hidrominerales S. de RL. de C.V.
Date Published : 08/27/2020
Avenida 5 De Mayo 600 , San Gregorio Atzompa
, Chipilo De Francisco Javier Mina (Chipilo),
Puebla MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/27/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/27/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/27/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/27/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/27/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/27/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/27/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/27/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/27/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Maquiladora Miniara SA de CV
Date Published : 07/16/2020
Carretera Teoloyucan Huehuetoca Km. 22 , Coyotepec
, Coyotepec,
Mexico MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/16/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/16/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Marco Antonio Rodriguez Fierro
Date Published : 09/28/2020
Avenida Las Americas 409 , Col. Leon Xiii, Guadalupe
, Guadalupe,
Nuevo Leon MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/28/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/28/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 09/28/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 09/28/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 09/28/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 09/28/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 09/28/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 09/28/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 09/28/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Nanomateriales Quimicos Avanzados SA de CV
Date Published : 08/31/2020
Avenida Milimex 215 , Col. Milimex, Apodaca
, Ciudad Apodaca,
Nuevo Leon MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/31/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/31/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/31/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/31/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/31/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/31/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/31/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/31/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/31/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Neoingenium Labs, SA de CV
Date Published : 09/18/2020
Periferico Poniente Manuel Gomez Morin 6370 , Col. Ciudad Granja, Zapopan
, Zapopan,
Jalisco MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/18/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/18/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 09/18/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 09/18/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 09/18/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 09/18/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 09/18/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 09/18/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 09/18/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Notarika S.A. de CV
Date Published : 08/11/2020
Prolongacion 5 De Mayo 35 , Col. Parque Industrial
, Naucalpan,
MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Notarika, S.A. de C.V.
Date Published : 08/11/2020
Elctrica De Mxico No. 41 Vista Hermosa , Tlalnepantla De Baz
, Tlalnepantla De Baz,
Mexico MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/11/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Noticias Mexico Hoy Grupo Multimedia, S.A. de C.V.
Date Published : 08/21/2020
Privada Rio Atoyac No.23 Puebla (Rancho Colorado )
, Puebla,
MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/21/2020
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/21/2020
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/21/2020
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/21/2020
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/21/2020
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/21/2020
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/21/2020
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/21/2020
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/21/2020
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Plasticos Las Palmas, S.A. de C.V.
Date Published : 08/06/2020
Vereda De Las Violetas 19 , Col. Los Sauces, Tlajomulco De Zuniga
, Tlajomulco De Zuniga,
Jalisco MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/06/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/06/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/06/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/06/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/06/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/06/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/06/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/06/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/06/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Precision Analitica Integral S.A. de C.V.
Date Published : 08/13/2020
Calle De Minas No. 501 Bodega 21 , Col. Arvide, Alvaro Obregon
, Ciudad De Mexico,
Ciudad de Mexico MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Quimica Magna de Mexico, S.A. de C.V.
Date Published : 07/15/2020
Telares No. 130 La Aurora
, Saltillo,
Coahuila de Zaragoza MEXICO
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 07/15/2020
Desc: All Drug and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 07/15/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Real Clean Distribuciones SA de CV
Date Published : 07/16/2020
Recursos Petroleros , Fracc Industrial La Loma 3; Tlalnepantla De Baz
, Tlalnepantla De Baz,
Mexico MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/16/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/16/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 07/16/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Roque Plast S.A. De C.V.
Date Published : 08/13/2020
Cda. Adolfo Manfredi No. 7ind. El
, Atizapan De Zaragoza East,
MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 08/13/2020
Notes: All Drugs and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Simex Logistics SA de CV
Date Published : 11/17/2020
Calle Salvatierra Fracc. El Puente 101 , Col. Santa Maria, Celaya
, Celaya,
Guanajuato MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 11/17/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 11/17/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 11/17/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 11/17/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 11/17/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 11/17/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 11/17/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 11/17/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 11/17/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Soluciones Cosmeticas, SA de CV
Date Published : 07/10/2020
Avenida Ano De Juarez 110 , Otro Granjas San Antonio, Iztapalapa
, Ciudad De Mexico,
Ciudad de Mexico MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/10/2020
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
Tropicosmeticos, S.A. de C.V.
Date Published : 07/10/2020
Av Via Morelos No 60 Bodega 9 Rustica
, Xalostoc, Ecatepec De Morelos,
Mexico MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 07/10/2020
Notes: All Drug and Drug Products; All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
YARA ELENA DE LA GARZA PEREZ NIETO
Date Published : 07/17/2020
Gustavo V 179. Puertas Del Rey , Saltillo
, Saltillo,
Coahuila de Zaragoza MEXICO
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 07/17/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 07/17/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 07/17/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 07/17/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 07/17/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 07/17/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 07/17/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 07/17/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 07/17/2020
Notes: All Drug and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
POLAND
BIONATEO SP ZOO
Date Published : 06/07/2021
Ul. Chocimska 6
, Kalisz,
Wielkopolskie POLAND
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 06/07/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 06/07/2021
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 06/07/2021
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 06/07/2021
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 06/07/2021
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 06/07/2021
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 06/07/2021
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 06/07/2021
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 06/07/2021
Notes: All Drugs and Drug Products
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
TURKEY
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil
Date Published : 05/17/2021
Bolgesi Aydinli Sb Mahallesi , 6 12 Istanbul Endustri Veticaret Serbest
, Sokak Tuzla,
Istanbul TURKEY
53 I - - 02 Mouthwashes and Breath Fresheners (Liquids and Sprays), without Fluoride (Oral Hygiene Products)
Date Published: 05/17/2021
Desc: All Drugs and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 05/17/2021
Desc: All Drugs and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/17/2021
Desc: All Drugs and Drug Products
Notes: All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 05/17/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 05/17/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 05/17/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 05/17/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 05/17/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 05/17/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 05/17/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 05/17/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 05/17/2021
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
SCK Zeta Dis Ticaret Pazarlama Limited Sirketi
Date Published : 09/22/2020
Isyeri 4, No:81 Buyukdere Caddesi
, Istanbul,
Istanbul TURKEY
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 09/22/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
56 - - - -- Antibiotics (Human/Animal)
Date Published: 09/22/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022
60 - - - -- Human and Animal Drugs
Date Published: 09/22/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
61 - - - -- Human and Animal Drugs
Date Published: 09/22/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
62 - - - -- Human and Animal Drugs
Date Published: 09/22/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
63 - - - -- Human and Animal Drugs
Date Published: 09/22/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
64 - - - -- Human and Animal Drugs
Date Published: 09/22/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
65 - - - -- Human and Animal Drugs
Date Published: 09/22/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.
66 - - - -- Human and Animal Drugs
Date Published: 09/22/2020
Notes: All Drugs and Drug Products;
All drug and drug products appear to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP requirements.