FDA WARNING_LETTER - Captain's Fine Foods, LLC - March 02, 2011

An FDA inspection of Captain's Fine Foods, LLC, conducted from February 23 to March 2, 2011, revealed 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). Consequently, the firm's ready-to-eat pasteurized crabmeat and King (Spanish) Mackerel 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. Key violations included the failure to implement monitoring procedures and frequencies as listed in the HACCP plan for Pasteurized Refrigerated Crab, specifically regarding continuous temperature recording at the "Crab Storage" critical control point (21 CFR 123.6(b) and (c)(4)). Additionally, the firm's corrective action plans for Pasteurized Refrigerated Crab and King Mackerel at the "Crab Receiving" and "Receiving" critical control points were found to be inappropriate, as they did not assure the cause of deviation was corrected or adequately describe evaluation methods (21 CFR 123.7(b)). The FDA emphasized the firm's responsibility for ensuring product safety, even for products received from other processors. Captain's Fine Foods, LLC, was required to respond in writing within fifteen working days, detailing specific corrective actions and providing supporting documentation. Failure to promptly correct these violations could result in further actions, including product seizure or an injunction against the firm's operations.