FDA WARNING_LETTER - AMERICAN FOOD DISTRIBUTOR INC - July 15, 2025

On September 8, 2025, the FDA issued a Warning Letter to American Food Distributor Inc., following an inspection conducted from July 2 to July 15, 2025, at their Romulus, MI facility. The inspection assessed the company"s adherence to the Foreign Supplier Verification Program (FSVP) requirements, as mandated by section 805 of the Federal Food, Drug, and Cosmetic Act and its implementing regulation (21 CFR part 1, subpart L). The FSVP regulation requires importers to perform risk-based activities to ensure imported human and animal food meets U.S. food safety standards. The primary violation identified was the company"s failure to develop, maintain, and follow an FSVP for any of the foods they import, specifically citing Tahina, Extra Virgin Olive Oil, and Mallow leaves. This constitutes a significant non-compliance with the established regulatory framework. American Food Distributor Inc. is required to respond in writing within fifteen working days, outlining specific corrective actions taken. This response must include supporting documentation, such as a copy of their developed FSVP and records demonstrating its implementation. Failure to adequately address these issues could result in further regulatory action, including the refusal of admission for their imported food products.