FDA WARNING_LETTER - Mr. Seafood Distributors - March 11, 2008

On March 4 and 11, 2008, the FDA inspected Mr. Seafood Distributors, a seafood processing and importer establishment, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the current Good Manufacturing Practice regulation for foods (21 CFR Part 110).

The firm failed to conduct a hazard analysis and implement a written HACCP plan for ready-to-eat refrigerated pasteurized canned crabmeat to control the food safety hazard of pathogen growth, violating 21 CFR 123.6(a) and (b). This renders the firm's pasteurized canned crabmeat, frozen octopus, scombrotoxin-forming species, and fresh shellfish adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(4), as they were prepared, packed, or held under insanitary conditions.

As an importer, the firm also failed to ensure imported fish and fishery products complied with 21 CFR Part 123, as required by 21 CFR 123.12(d). Failure to correct these violations may result in refusal of admission of imported products, detention without physical examination, seizure of products, and/or injunction. The firm must respond in writing within