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). ***
***All allergenic products including allergenic extracts, pre-filled syringes with allergen extracts, antigen skin tests, and allergen patch tests***
"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
***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. **
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: 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). ***
Country-specific information is available in the full alert detail on the FDA website.
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