FDA WARNING_LETTER - SDJJ Distributors - January 18, 2022

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of SDJJ Distributors from January 11-18, 2022, following a prior inspection in August 2019. The purpose was to determine compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1, subpart L, which requires importers to perform risk-based activities to verify imported food meets U.S. safety standards. The inspection revealed significant violations, specifically that SDJJ Distributors failed to develop, maintain, and follow an FSVP for any of the food products it imports, as mandated by section 805 of the FD&C Act and 21 CFR 1.502(a). A Form FDA 483a was issued, but no response has been received. Failure to adequately address these violations may lead to refusal of admission for imported food, detention without physical examination (DWPE) under Import Alert # 99-41, and prohibition of importation under section 301(zz) of the FD&C Act. SDJJ Distributors must respond in writing within fifteen working days, detailing corrective actions, providing supporting documentation, and explaining any delays.