FDA WARNING_LETTER - Sociedad Guidomar Ltda - May 23, 2014

On May 22-23, 2014, the FDA inspected Sociedad Guidomar Ltda's seafood processing facility in Coquimbo, Chile, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The firm's frozen, cooked crustaceans (langostino tailmeat and shrimp) are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis and Critical Control Points (CCPs):** The revised HACCP plan (Version 14) for cooked crustaceans failed to list critical control points for pathogenic bacteria growth and toxin formation. Specifically, it omitted refrigerated storage after cooking and all post-cook processing steps prior to freezing as CCPs, despite extensive handling and potential for contamination. 2. **Inadequate Critical Limits:** The HACCP plan listed inadequate critical limits for controlling pathogenic bacteria. For the "Cooling" CCP, the critical limit was insufficient; FDA recommends cooling to below 21.1°C within 1 hour and limiting exposure between 21.1°C and 10°C to 3 hours. Another critical limit for cooked shrimp handling between 21.1°C and 10°C did not include the time held, which should be part of the total cumulative time exposure.