FDA WARNING_LETTER - The Great Smart African Food LLC - December 16, 2025

The FDA issued a Warning Letter to The Great Smart African Food LLC on January 15, 2026, following an inspection from October 23, 2025, to December 16, 2025. This inspection assessed the company"s compliance with the Foreign Supplier Verification Program (FSVP) regulation, which mandates importers to verify that foreign-supplied food meets U.S. food safety standards. The primary violation identified was the company"s failure to develop, maintain, and follow an FSVP for imported foods, including Maize Flour, Peanut Butter Biscuits, and Dried Milk. The documents provided by the company during the inspection, such as invoices and Bills of Lading, were not clearly explained or applied to an FSVP program. This constitutes a significant violation of Section 805 of the Federal Food, Drug, and Cosmetic Act and its implementing regulations (21 CFR part 1, subpart L). The FDA noted the absence of a response to the Form FDA 483a (FSVP Observations) issued at the inspection"s conclusion. The company is required to respond in writing within fifteen working days, detailing specific corrective actions taken, providing supporting documentation, and explaining any anticipated delays. Failure to adequately address these violations may lead to further regulatory actions, including the refusal of admission for imported food.