Import Alert 55-05

(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 # 55-05
Published Date: 01/18/2024
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination Of Finished Dosage Form Drug Products, Active Pharmaceutical Ingredients, and Inactive Ingredients for Potentially Hazardous Microbiological Contamination"

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 10/15/2021 updates the name of the alert, reason for alert, guidance section, and charge section. Changes to the import alert are bracketed by asterisks (***).

***FDA collects and analyzes samples of finished dosage form drug products, active pharmaceutical ingredients (APIs), and inactive ingredients considered at risk for potentially hazardous microbial contamination that pose a health risk. Detention without physical examination may be appropriate when sample results reveal a potential health risk. ***

Guidance:

Divisions may detain, without physical examination, shipments of the products identified on the Red List of this Alert.

If the article appears to be adulterated due to nonadherence to current good manufacturing practice (CGMP) requirements (DRUG GMPS) and is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA considers reconditioning or submission of analytical results to be insufficient to overcome the appearance of the violation.

Recommendation for addition to DWPE under this import alert when analytical results reveal the presence of potentially hazardous microbial contamination of finished dosage form drug products, APIs, or inactive ingredients intended for pharmaceutical use should be forwarded to the 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 concurrence. ***

*** Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
Firms that would like to be removed from DWPE should provide information to FDA to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. This may include a letter detailing the firm's corrective actions, accompanied by supporting documentation. 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, via email to: Importalerts2@fda.hhs.gov.***

***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, 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 drug products, APIs, or inactive ingredients should be addressed to CDER/OC/ODSIR/DGDDP/ICB at CDERImports@fda.hhs.gov ***

Product Description:

CDER regulated finished dosage form drug products, active pharmaceutical ingredients, and inactive ingredients

Charge:

*** The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that the article contains potentially hazardous, or otherwise objectionable in light of intended use, microbial adulteration and therefore consists in part of a filthy substance. [Adulteration, Section 501(a)(1)]

OASIS CHARGE CODE: FILTH

AND/OR

The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions [Insanitary Manufacturing, Processing or Packing, Section 801(a)(1)]

OASIS CHARGE CODE: MFR INSAN

AND/OR

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

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 ***

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


CANADA


Delta Pharma Inc.
Date Published : 05/22/2013
1655 Rte Transcanadienne , Dorval, Quebec CANADA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 05/22/2013

Desc: Face Values for Baby Healing Ointment
Notes: Problem(s): FILTH 501(a)(1); INSANITARY 501(a)(2)(A)


CHINA


GFA Production Xiamen Co., Ltd.
Date Published : 02/16/2023
Huli Industrial Park, Tong'an District , 20 Meixi Avenue , Xiamen, Fujian CHINA
55 Q - - 41 Benzalkonium Chloride (Pharmaceutic Necessity - Preservative)
Date Published: 02/16/2023

Desc: Easy Care First Aid Burn Cream
Notes: 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)].

56 Y - - 99 Antibiotic N.E.C.
Date Published: 02/16/2023

Desc: Easy Care First Aid Burn Cream
Notes: 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)].

60 F - - 99 Adsorbant N.E.C.
Date Published: 02/16/2023

Desc: Easy Care First Aid Burn Cream
Notes: 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)].

60 L - - 99 Analgesic, N.E.C.
Date Published: 02/16/2023

Desc: Easy Care First Aid Burn Cream
Notes: 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)].

60 Q - - -- Anesthetic
Date Published: 02/16/2023

Desc: Easy Care First Aid Burn Cream
Notes: 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)].

61 H - - 99 Anti-Bacterial, N.E.C.
Date Published: 02/16/2023

Desc: Easy Care First Aid Burn Cream
Notes: 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)].

62 F - - 99 Anti-Infective, Topical N.E.C.
Date Published: 02/16/2023

Desc: Easy Care First Aid Burn Cream
Notes: 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)].

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 02/16/2023

Desc: Easy Care First Aid Burn Cream
Notes: 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)].

79 - - - -- General & Plastic Surgery
Date Published: 02/16/2023

Desc: Easy Care First Aid Burn Cream
Notes: 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)].


INDIA


Contacare Ophthalmics & Diagnostics
Date Published : 08/23/2017
310b Village Sim , Block No , Dabhasa, Gujarat INDIA
55 R P - 14 Hydroxypropyl Methylcellulose (Pharmaceutic Necessity - Suspending Agent), Pharma Necess
Date Published: 08/23/2017

Desc: Hydroxypropyl Methyl Cellulose
Notes: Problem(s): DRUG GMPs 501(a)(2)(B); DWPE applies to all aseptically processed drugs manufactured or shipped by Contacare Ophthalmics & Diagnostics, including Sodium Chloride ophthalmic solution.

55 R P - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent), Pharma Necess
Date Published: 08/23/2017

Desc: Sodium Chloride
Notes: Problem(s): DRUG GMPs 501(a)(2)(B); DWPE applies to all aseptically processed drugs manufactured or shipped by Contacare Ophthalmics & Diagnostics, including Sodium Chloride ophthalmic solution.

63 X C P 69 Iopydol (Diagnostic Aid) (Drugs), Human - Rx/Single Ingredient, Small Volume Parenteral <100ml
Date Published: 08/23/2017

Desc: Lopydol
Notes: Problem(s): DRUG GMPs 501(a)(2)(B); DWPE applies to all aseptically processed drugs manufactured or shipped by Contacare Ophthalmics & Diagnostics, including Sodium Chloride ophthalmic solution.

63 X - - 12 Fluorescein Sodium (Diagnostic Aid) (Drugs)
Date Published: 08/23/2017

Desc: Fluorescein Sodium
Notes: Problem(s): DRUG GMPs 501(a)(2)(B); DWPE applies to all aseptically processed drugs manufactured or shipped by Contacare Ophthalmics & Diagnostics, including Sodium Chloride ophthalmic solution.

63 X - - 99 Diagostic Aid (Drugs) N.E.C.
Date Published: 08/23/2017

Desc: Sodium Chloride
Notes: Problem(s): DRUG GMPs 501(a)(2)(B); DWPE applies to all aseptically processed drugs manufactured or shipped by Contacare Ophthalmics & Diagnostics, including Sodium Chloride ophthalmic solution.

65 R A K 19 Sodium Chloride (Replenisher), Human - Non/Rx Single Ingredient, Sterile Liquid
Date Published: 08/23/2017

Desc: Sodium Chloride
Notes: Problem(s): DRUG GMPs 501(a)(2)(B); DWPE applies to all aseptically processed drugs manufactured or shipped by Contacare Ophthalmics & Diagnostics, including Sodium Chloride ophthalmic solution.

65 R D K 12 Potassic Saline (Injection) (Replenisher), Human - Rx/Combination Ingredient, Sterile Liquid
Date Published: 06/22/2021

Desc: Potassic Saline
Notes: Problem(s): DRUG GMPs 501(a)(2)(B) DWPE applies to all aseptically processed drugs manufactured or shipped by Contacare Ophthalmics & Diagnostics, including Sodium Chloride ophthalmic solution.


KOREA (THE REPUBLIC OF)


Neo Vision Co., Ltd.
Date Published : 12/13/2016
93 Jeungsin-Ro , Icheon, Gyeonggi KOREA (THE REPUBLIC OF)
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 12/13/2016

Notes: All drugs and drug products Problem(s): DRUG GMPs 501(a)(2)(B)

56 - - - -- Antibiotics (Human/Animal)
Date Published: 12/13/2016

Notes: All drugs and drug products Problem(s): DRUG GMPs 501(a)(2)(B)

58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs
Date Published: 05/26/2022

60 - - - -- Human and Animal Drugs
Date Published: 12/13/2016

Notes: All drugs and drug products Problem(s): DRUG GMPs 501(a)(2)(B)

61 - - - -- Human and Animal Drugs
Date Published: 12/13/2016

Notes: All drugs and drug products Problem(s): DRUG GMPs 501(a)(2)(B)

62 - - - -- Human and Animal Drugs
Date Published: 12/13/2016

Notes: All drugs and drug products Problem(s): DRUG GMPs 501(a)(2)(B)

63 - - - -- Human and Animal Drugs
Date Published: 12/13/2016

Notes: All drugs and drug products Problem(s): DRUG GMPs 501(a)(2)(B)

64 - - - -- Human and Animal Drugs
Date Published: 12/13/2016

Notes: All drugs and drug products Problem(s): DRUG GMPs 501(a)(2)(B)

65 - - - -- Human and Animal Drugs
Date Published: 12/13/2016

Notes: All drugs and drug products Problem(s): DRUG GMPs 501(a)(2)(B)

66 - - - -- Human and Animal Drugs
Date Published: 12/13/2016

Notes: All drugs and drug products Problem(s): DRUG GMPs 501(a)(2)(B)


MEXICO


Brady Mexico S De RL de CV
Date Published : 08/26/2016
Guerrero Negro , Tijuana, BC MEXICO
55 R - - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent)
Date Published: 08/26/2016

Desc: Eyesaline Eyewash
Notes:                                                                                                                                                                                                                                

55 R - - 56 Ethyl Oleate (Pharmaceutic Necessity - Vehicle)
Date Published: 08/26/2016

Desc: Eyesaline Eyewash
Notes:                                                                                                                                                                                                                                

65 F - - 06 Water, Purified (Eyewash)
Date Published: 08/26/2016

Desc: Eyesaline Eyewash
Notes:                                                                                                                                                                                                                                

65 R - - 12 Potassic Saline (Injection) (Replenisher)
Date Published: 08/26/2016

Desc: Eyesaline Eyewash
Notes:                                                                                                                                                                                                                                


UNITED STATES


Sperian Eye & Face Protection Inc
Date Published : 08/26/2016
825 E Business Highway 151 , Platteville, WI 53818-3763 UNITED STATES
55 R - - 55 Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent)
Date Published: 08/26/2016

Desc: Eyesaline Eyewash

55 R - - 56 Ethyl Oleate (Pharmaceutic Necessity - Vehicle)
Date Published: 08/26/2016

Desc: Eyesaline Eyewash

65 F - - 06 Water, Purified (Eyewash)
Date Published: 08/26/2016

Desc: Eyesaline Eyewash

65 R - - 12 Potassic Saline (Injection) (Replenisher)
Date Published: 08/26/2016

Desc: Eyesaline Eyewash