FDA WARNING_LETTER - Amin Trading Agency LLC - March 04, 2024

On December 27, 2023, through March 4, 2024, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Amin Trading Agency LLC in Edison, NJ, following a previous inspection from October 4 to November 10, 2022. The inspections assessed compliance with section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) and 21 CFR part 1, subpart L, which mandate risk-based activities for importers to verify that imported human and/or animal food meets U.S. food safety standards.

The FDA found that Amin Trading Agency LLC is not in compliance with these requirements. Specifically, the firm failed to develop, maintain, and follow an FSVP for foods imported from foreign suppliers, as required by 21 CFR part 1.502(a). This significant violation means the firm is not in compliance with section 805 of the FD&C Act. An FDA 483a FSVP Observations form was issued on March 4, 2024, but no response has been received.

Failure to adequately address these violations may lead to further FDA action, including refusal of admission for imported food under section 801(a)(3) of the FD&C Act, and potential detention without physical examination (DWPE) under Import Alert #99-41.