FDA WARNING_LETTER - Sharkco Seafood International L.L.C. - August 13, 2012

On August 8, 2012, an FDA investigator inspected Sharkco Seafood International, LLC, in Venice, Louisiana, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Consequently, the firm's fish and shrimp products are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The primary violations include the firm's HACCP plan for various fish and shrimp products failing to list "Storage" as a Critical Control Point (CCP) for controlling pathogenic bacteria growth and toxin formation, as required by 21 CFR 123.6(a) and (c)(2). Additionally, the HACCP plan for certain fish, such as bee liner, black grouper, gag grouper, and lane snapper, does not list ciguatera toxin as a reasonably likely food safety hazard, violating 21 CFR 123.6(a) and (c)(1). The firm's response, dated August 13, 2012, was deemed inadequate due to unclear verification processes, lack of internal temperature monitoring, and missing essential plan details like product description and intended use. FDA requires a written response within fifteen working days outlining specific corrective actions, including complete HACCP and verification records. Failure to correct these violations may result in further actions, including product seizure, injunction, and assessment of re-inspection fees.