American Fish & Seafood Co. – FDA Warning Letter, Feb 2, 2012

The FDA inspected American Fish & Seafood Company's facility in Sacramento, California, on January 23, 25, 30, and February 2, 2012, finding serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110). These violations render their chilled, histamine-forming fish (e.g., tuna), chilled vacuum-packaged Hamachi and tuna, refrigerated ready-to-eat products (e.g., vacuum-packaged smoked salmon and trout), and pasteurized canned crabmeat adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis:** The HACCP plan for histamine-producing finfish did not list pathogen growth and toxin formation as a hazard for Sashimi grade fish intended for raw consumption at receiving and cooler storage. 2. **Inadequate Critical Limits:** Multiple HACCP plans had critical limits insufficient to control histamine formation or pathogen growth and toxin formation (including *Clostridium botulinum* toxin) at receiving and cooler storage CCPs. Specific examples include inadequate time/temperature limits for histamine control in finfish and for pathogen control in refrigerated vacuum-packaged smoked fish, ready-to-eat products, and scombroid