A.N.N. Imports LLC – FDA Warning Letter, Dec 22, 2021

On December 7-22, 2021, the FDA conducted a follow-up Foreign Supplier Verification Programs (FSVP) inspection of A.N.N. Imports LLC, building on a previous inspection from September 17, 2019. The inspection aimed to assess compliance with Section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FSVP regulation (21 CFR part 1 subpart L), which mandates importers perform risk-based activities to ensure imported food meets U.S. safety standards. The FDA found the firm not in compliance with these requirements, specifically citing a significant violation: the failure to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). Although some process flow charts and an inspection certificate were provided, they lacked explanation, application to an FSVP, or review records, and did not constitute a compliant FSVP. The FDA has not received a response to the Form FDA 483a issued. Failure to adequately address these violations may lead to refusal of admission for imported food under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert # 99-41, and is prohibited under section 301(zz). The firm must respond in writing within fifteen working days, detailing corrective actions with supporting documentation, such as a copy of their FSVP and implementation records.