Import Alert 57-15
(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 # 57-15
Published Date: 08/27/2024
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Unlicensed Allergenic Products"
Reason for Alert:
NOTE: The revision of this Import Alert, dated 08/27/2024, updates the title, the reason for alert section, the guidance section including removal from detention without physical examination under this import alert, agency contact information, product description section. Changes are bracketed by asterisks (***).
FDA has determined that the firms listed below have been sending unlicensed allergenic products to the United States (U.S.). ***Foreign establishments having a U.S. license for the manufacture of allergenic products also manufacture unlicensed versions of allergenic products. Only allergenic products manufactured under the U.S. license and bearing the U.S. license number on its labeling may be imported into the U.S. unless the unlicensed version of allergenic product has an Investigational New Drug (IND) application in effect with the Center for Biologics Evaluation and Research (CBER). ***
FDA has determined that the firms listed below have been sending unlicensed allergenic products to the United States (U.S.). ***Foreign establishments having a U.S. license for the manufacture of allergenic products also manufacture unlicensed versions of allergenic products. Only allergenic products manufactured under the U.S. license and bearing the U.S. license number on its labeling may be imported into the U.S. unless the unlicensed version of allergenic product has an Investigational New Drug (IND) application in effect with the Center for Biologics Evaluation and Research (CBER). ***
Guidance:
***Divisions may detain without physical examination the specified biologic product(s) from the firms on the Red List of this alert.
In addition to the products from the firms on the Red List of this alert, any other applicable allergenic products that are not manufactured at an establishment holding an unsuspended and unrevoked U.S. license issued under the PHS Act, Part F, Subpart 1 - Biological Products, Section 351 (a)(42 USC 262) or are not the subject of an Investigational New Drug application that is in effect, should be held for review.
All requests for addition to this DWPE will be evaluated by the Division of Import Operations (DIO) and CBER, Biological Drug and Device Compliance Branch.
NOTE: (For Allergen Delivery Systems/Patches) - Allergen delivery systems only that are pre-filled with allergenic extracts or unfilled allergen delivery systems that accompany allergenic extracts in shipping should be detained. Unfilled allergen delivery system components are not subject to this guidance.
NOTE: (For Oral Products in Liquid Form) - Unlicensed allergenic extracts in liquid formulations for sublingual or oral delivery should be detained.
Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm’s product 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 a 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. For guidance on removal from detention without physical examination, refer to FDA’s Regulatory Procedures Manual, Chapter 9-8, "Detention without Physical Examination (DWPE).”
If a firm and/or a representative thereof would like to submit a petition for removal from detention without physical examination 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
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
For questions regarding these criteria and/or products covered, contact CBER's Office of Compliance and Biologics Quality, Division of Case Management CBERImportInquiry@fda.hhs.gov or by phone at 240-402-9156.
**
In addition to the products from the firms on the Red List of this alert, any other applicable allergenic products that are not manufactured at an establishment holding an unsuspended and unrevoked U.S. license issued under the PHS Act, Part F, Subpart 1 - Biological Products, Section 351 (a)(42 USC 262) or are not the subject of an Investigational New Drug application that is in effect, should be held for review.
All requests for addition to this DWPE will be evaluated by the Division of Import Operations (DIO) and CBER, Biological Drug and Device Compliance Branch.
NOTE: (For Allergen Delivery Systems/Patches) - Allergen delivery systems only that are pre-filled with allergenic extracts or unfilled allergen delivery systems that accompany allergenic extracts in shipping should be detained. Unfilled allergen delivery system components are not subject to this guidance.
NOTE: (For Oral Products in Liquid Form) - Unlicensed allergenic extracts in liquid formulations for sublingual or oral delivery should be detained.
Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm’s product 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 a 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. For guidance on removal from detention without physical examination, refer to FDA’s Regulatory Procedures Manual, Chapter 9-8, "Detention without Physical Examination (DWPE).”
If a firm and/or a representative thereof would like to submit a petition for removal from detention without physical examination 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
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
For questions regarding these criteria and/or products covered, contact CBER's Office of Compliance and Biologics Quality, Division of Case Management CBERImportInquiry@fda.hhs.gov or by phone at 240-402-9156.
**
Product Description:
***All allergenic products including allergenic extracts, pre-filled syringes with allergen extracts, antigen skin tests, and allergen patch tests***
Charge:
"The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use.
[Misbranded, 801(a)(3), 505, 502(f)(1); UNAPPROVED, MISBRANDED & PHS ACT]
OASIS Charge Code: NO LICENSE
[Misbranded, 801(a)(3), 505, 502(f)(1); UNAPPROVED, MISBRANDED & PHS ACT]
OASIS Charge Code: NO LICENSE
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
CANADA
Dormer Laboratories Inc
Date Published : 09/10/2009
91 Kelfield St Unit 5
, Etobicoke,
Ontario CANADA
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 05/14/2010
Desc: All allergens and allergenic products
Notes: Other product codes:
b(7)(a)
b(7)(a)
b(7)(a)
b(7)(a)
b(7)(a)
SWEDEN
Chemotechnique Diagnostics
Date Published : 09/10/2009
Unknown Street
, Malmo,
SWEDEN
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 05/14/2010
Desc: All allergens and allergenic products
Notes: Other product codes:
b(7)(a)
b(7)(a)
b(7)(a)
b(7)(a)
b(7)(a)
Chemotechnique Diagnostics
Date Published : 09/10/2009
Box 80 28042
, Tygelsjo,
SWEDEN
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 05/14/2010
Desc: All allergenic and allergenic products
Notes: Other product codes:
b(7)(a)
b(7)(a)
b(7)(a)
b(7)(a)
b(7)(a)
UNITED KINGDOM
Mcewen Laboratories Limited
Date Published : 05/14/2010
12 Horseshoe Park
, Reading,
WBK UNITED KINGDOM
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 05/14/2010
Desc: Enzyme potientiated desentization products including Chondroitin X-Theta; Chondroitin X-E; Chondroitin I-C; Chondroitin LA; Chondroitin W; Chondroitin Formalin; Chondroitin P/K.C.; Chondroitin O&E; Chondroitin T; Chondroitin Bacteriodes; Chondroitin M; Chondroitin D
Notes: Other product codes:
b(7)(a)
b(7)(a)
b(7)(a)
b(7)(a)