FDA WARNING_LETTER - Blue Ribbon Fish Co. - August 13, 2008

The FDA inspected Blue Ribbon Fish Co.'s seafood processing facility in Bronx, New York, on August 11-13, 2008. The inspection revealed a serious violation 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). Specifically, the firm failed to have and implement a written HACCP plan for its refrigerated ready-to-eat pasteurized crab meat in hermetically sealed containers. This deficiency meant the firm lacked control over the food safety hazard of pathogen growth and toxin formation, particularly Clostridium botulinum, as required by 21 CFR 123.6(a) and (b). Consequently, the crab meat product was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The FDA recommended critical control points for temperature control during receipt and storage, including continuous monitoring devices and daily checks. The firm was instructed to respond in writing within fifteen working days, outlining specific corrective actions, including HACCP and verification records. Failure to promptly correct the violation could lead to further actions, such as product seizure or injunction against operations, highlighting significant business and operational implications. The letter also emphasized the firm's responsibility for overall compliance with all applicable regulations.