FDA WARNING_LETTER - Tropical Seafood - July 17, 2012

On October 4, 2012, the FDA issued a Warning Letter to Tropical Seafood, Inc. following an inspection of their seafood processing facility in Golden Meadow, Louisiana, conducted on July 11-13, 16, and 17, 2012. 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 primary violation identified was the firm's failure to have and implement a written HACCP plan for shrimp to control food safety hazards such as environmental contaminants and sulfites, as required by 21 CFR 123.6(a) and (b). The submitted HACCP plan, dated July 26, 2012, was deficient as it failed to list seafood products and lacked documentation for monitoring received product batches. If controlling contaminants at the receiving step, a supplier certificate is required.

These violations render the firm's shrimp adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 USC 342(a)(4)), meaning they were prepared, packed, or held under insanitary conditions.

Tropical Seafood, Inc. must respond in writing within fifteen working days, outlining specific corrective actions, including a revised HACCP plan and