FDA WARNING_LETTER - Florida's Finest Seafood Company - March 08, 2012

The FDA inspected Florida's Finest Seafood Company from February 28 to March 8, 2012, and identified serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). These violations render the firm's fish and fishery products, including histamine forming fish, pasteurized crabmeat, and smoked salmon, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions. Specific deficiencies include the failure to have HACCP plans that list adequate critical limits (21 CFR 123.6(c)(3)), critical control points (21 CFR 123.6(c)(2)), and monitoring procedures and frequencies (21 CFR 123.6(c)(4)). The firm also failed to implement listed monitoring procedures and frequencies (21 CFR 123.6(b) and (c)(4)), implement the record-keeping system (21 CFR 123.6(b) and (c)(7)), and verify the adequacy of its HACCP plan (21 CFR 123.8(a)). The FDA requires a written response within fifteen working days detailing corrective actions, including supporting documentation. Failure to correct these violations may result in further action, such as product seizure or an injunction against the firm's operations.