Pacific Hi - Tak Inc – FDA Warning Letter, Aug 21, 2014

On December 5, 2014, the FDA issued a Warning Letter to Pacific Hi-Tak Incorporated following an inspection from August 12-21, 2014. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their refrigerated, vacuum-packaged, and non-vacuum-packaged fresh Yellowtail (Hamachi) fillets adulterated.

Key violations included: * **Inadequate HACCP Plan Monitoring Procedures:** The HACCP plan for vacuum-packaged fresh Yellowtail fillets lacked adequate monitoring procedures for Clostridium botulinum toxin formation at the refrigerated storage critical control point, specifically omitting daily visual checks of recorded data to ensure temperatures of 38°F or below. * **Inadequate Critical Limits:** The HACCP plan's critical limits for receiving (e.g., "adequate quantity of frozen gel packs," "near surface fish temperature maintained at 38°F or below") were insufficient to control Clostridium botulinum toxin formation, pathogenic bacteria growth, and histamine, as they did not ensure proper temperatures for all fish. FDA recommended monitoring internal temperatures and ensuring gel packs completely surround the fish. Similarly, refrigerated storage critical limits were deemed inadequate, with FDA recommending continuous temperature monitoring. * **Failure to Implement Monitoring Procedures and Recordkeeping:** The firm failed to follow monitoring procedures at the receiving critical control point for