United States Cold Storage, Inc. – FDA Warning Letter, Oct 17, 2011

On December 1, 2011, the FDA issued a Warning Letter to United States Cold Storage, Inc. following an inspection from October 12-17, 2011, at their Medley, FL seafood processing establishment. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

The FDA determined that the firm's pasteurized crab, amberjack/yellowtail, herring, mackerel, mahi mahi, smoked fish, and smoke-flavored, salted fish were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Inadequate Critical Limits:** HACCP plans for "pasteurize crab meat," "smoked fish, smoked flavored, salted fish," and "amberjack/yellowtail, herring, mackerel, mahi mahi" listed critical limits (e.g., "product must be less than 40 °F" or "at or below 38°F") at receiving critical control points that were insufficient to control pathogenic bacteria growth, Clostridium botulinum toxin formation, and scombrotoxin (histamine) formation, failing to ensure products were not temperature abused during transit