ocean queen usa, inc., – FDA Warning Letter, Jan 13, 2014

On January 8, 9, and 13, 2014, the FDA inspected a seafood processing facility at 1650 Delta Court, Hayward, California, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110). These violations render histamine-forming fish and fishery products, including raw, ready-to-eat tuna, vacuum-packaged yellowtail, and raw, ready-to-eat salmon, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. **Inadequate Hazard Analysis:** HACCP plans for various fish products (e.g., Yellowtail, Salmon) failed to list reasonably likely food safety hazards such as histamine toxin formation and pathogen growth/toxin formation. 2. **Missing Critical Control Points (CCPs):** The HACCP plan for "Fresh Salmon – refrigerated (aquaculture)" did not list Thawing as a critical control point to control pathogen growth and toxin formation for raw consumption. 3. **Inadequate Critical Limits:** Critical limits in HACCP plans for "FRESH Fish Histamine Producing Fish," "Fresh Large Tuna," "Fresh Salmon," and vacuum-packaged fish were insufficient to control histamine formation,