Four Sea's Inc. – FDA Warning Letter, Nov 12, 2010

On March 2, 2011, the FDA issued a Warning Letter to Four Sea's Inc. following an inspection of their seafood processing facility in Boston, MA, on November 9, 10, and 12, 2010. 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 refrigerated pasteurized crabmeat and refrigerated fresh tuna were 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. **Inadequate HACCP Plan for Canned Pasteurized Crabmeat:** The HACCP plan's monitoring procedure for "temperature" at receiving and storage was insufficient to control pathogen growth and toxin formation, particularly *Clostridium botulinum*. The FDA recommended continuous temperature monitoring during transit and requiring continuous temperature records as a condition of receipt to ensure product temperatures did not exceed 40°F. 2. **Failure to Implement Monitoring Procedures for Scombrotoxin Fish:** The firm did not follow its HACCP plan's "visual" examination of "adequacy of cooling medium" at the "Receiving Scombrotoxin Fish