Sol Fish Traders – FDA Warning Letter, Nov 21, 2012

On November 21, 2012, the FDA issued a Warning Letter to Sol Fish Traders, based on an evaluation of their HACCP plan and supporting documentation for tuna products, submitted on May 19, 2012. The FDA found serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their tuna products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** The HACCP plan for (b)(4) tuna failed to list parasites and undeclared allergens as reasonably likely food safety hazards, despite the product being intended for raw consumption and the firm's responsibility for species declaration. 2. **Insufficient Critical Control Points (21 CFR 123.6(c)(2)):** The HACCP plan listed only "receiving" as a critical control point. The FDA noted the need for additional critical control points to control temperature during processing (e.g., (b)(4)) to prevent histamine formation, especially for ready-to-eat products. 3. **Missing Critical Limits (21 CFR 123.6(c)(3)):** The plan lacked a critical limit for decomposition