FDA WARNING_LETTER - BCS African Wholesale Food Supply Inc. - March 03, 2010

The FDA issued a Warning Letter to BCS African Wholesale Food Supply Inc. following inspections from February to April 2010 at their Brooklyn Park, Minnesota facility. The inspections revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (GMP) regulation (21 CFR Part 110). Consequently, the firm's uneviscerated smoked/dried fish, other smoked/fresh fish, and various packaged food products (palm oil, rice, beans) were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Key violations included the failure to conduct a hazard analysis for uneviscerated smoked dried fishery products exceeding 5 inches, posing a Clostridium botulinum risk. The firm also lacked product specifications for imported "bony fish," crayfish, and tilapia to address pathogen growth (21 CFR 123.12(a)(2)(i)) and failed to implement affirmative steps to ensure these imported products complied with seafood HACCP (21 CFR 123.12(a)(2)(ii)). Furthermore, the company did not monitor sanitation conditions and practices with sufficient frequency (21 CFR 110 & 123.11(b)), evidenced by issues like food debris on equipment, clogged sinks, damaged freezers, pests, and food buildup on drums. The FDA requires a written response within 15 working days detailing corrective actions and supporting documentation, warning of potential product seizure or operational injunction if violations are not promptly addressed.