Gulfish LP – FDA Warning Letter, Nov 8, 2011

On November 7 and 8, 2011, the FDA inspected Gulfish, LP's seafood processing facility in San Francisco, California, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render the firm's refrigerated, scombrotoxin-forming fish (e.g., Almaco Jack, Escolar, Barracuda) and refrigerated, ready-to-eat fish and fishery products (e.g., cooked blue crabmeat) adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. **Lack of HACCP Plan:** The firm lacks a HACCP plan for fresh chilled scombrotoxin-forming fish to control histamine formation during receipt and storage (21 CFR 123.6(a) and (b)). 2. **Incomplete HACCP Plan:** The HACCP plan for "Packaged Cooked Crab" fails to list pathogen growth and toxin formation as a reasonably likely food safety hazard, despite being identified in the Hazard Analysis Worksheet (21 CFR 123.6(a) and (c)(1)). 3. **Missing Critical Control Points:** The "Packaged Cooked Crab" HACCP plan does not list Receiving and Cooler Storage as critical control points for controlling