FDA WARNING_LETTER - Pacific Harvest Seafoods, Inc. - March 29, 2013

On May 1, 2013, the FDA issued a Warning Letter to Pacific Harvest Seafoods, Inc. following an inspection from March 27-29, 2013. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their seafood products, including fresh, refrigerated Mahi Mahi and ready-to-eat refrigerated, cooked Dungeness Crabmeat, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plan:** The firm lacked a HACCP plan for receiving and storing ready-to-eat refrigerated, cooked Dungeness Crabmeat to control *Clostridium botulinum* growth and toxin formation. 2. **Inadequate Hazard Analysis:** The HACCP plan for refrigerated Mahi Mahi ("Fresh Tuna, Mahi and Ono") failed to list undeclared allergens (finfish) as a food safety hazard. 3. **Inadequate Critical Limits:** The Mahi Mahi HACCP plan's critical limit at the "Receiving" critical control point was insufficient to control histamine formation. The firm's documented monitoring of incoming Mahi Mahi shipments was also inadequate. 4. **Inadequate Monitoring Procedures:** The Mahi Mahi HACCP plan's monitoring procedures and frequency for "Receiving" and "