24/7 Seafood Distributor, Corp. – FDA Warning Letter, May 23, 2011

On September 6, 2011, the FDA issued a Warning Letter to 24/7 Seafood Distributor Corp. following an inspection on May 23, 2011, which revealed serious violations of seafood HACCP (21 CFR 123) and CGMP (21 CFR 110) regulations. The firm's raw, fresh, refrigerated scombroid fish products, including sushi-grade tuna, whole, filleted, and/or loined tuna, escolar, and wahoo, were deemed adulterated.

Key violations included: 1. **Inadequate HACCP Plan:** The HACCP plan for "Fresh, Whole Filleted or Loined Tuna[,] Escolar and Wahoo" failed to list pathogenic bacteria growth as a reasonably likely food safety hazard, especially for sushi-grade tuna intended for raw consumption, at receiving and product storage CCPs. 2. **Failure to Implement Recordkeeping:** The firm did not record monitoring observations at receiving and product storage CCPs to control histamine formation, with records for "Product Receiving Records" and "Cooler Temperature/Presence of Ice Surrounding Product" not completed since February and March 2011, respectively. 3. **Inappropriate Corrective Actions:** Corrective action plans for receiving and product storage CCPs were inadequate, failing to prevent recurrence of critical limit deviations or ensure product safety after deviations. 4. **Insufficient Sanitation