FDA WARNING_LETTER - Able Cold Storage & Trucking - November 15, 2010

On March 28, 2011, the FDA issued a Warning Letter to Able Cold Storage and Trucking following an inspection from October 29 to November 15, 2010. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123).

The firm's smoked uneviscerated fish, smoked ground crayfish, and smoked shrimp were deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under insanitary conditions.

Specific violations included: 1. Failure to conduct a hazard analysis for smoked uneviscerated fish, specifically regarding uneviscerated fish over 5 inches, which FDA considers adulterated regardless of storage or packaging. 2. Lack of a written HACCP plan for smoked ground crayfish and smoked shrimp to control hazards like sulfites and pathogens. 3. Failure to conduct a hazard analysis and implement a HACCP plan for other refrigerated seafood products received and held for distribution, especially concerning transport times exceeding four hours where continuous time and temperature monitoring is recommended.

The FDA stated that failure to promptly correct these violations could result in further action, including product seizure and/or injunction against the firm's operation. The firm was required to respond in writing within 15 working days, outlining specific