FDA WARNING_LETTER - Trinidad Dock & Fishing Services Ltd - September 10, 2007

An FDA inspection conducted from September 4-10, 2007, at a U.S. importer (Nu-Wave Seafood Consultants, LLC) revealed that Trinidad Dock & Fishing Services Ltd. was supplying various fish and fishery products, including Yellow Fin Tuna, Big Eye Tuna, Albacore Tuna, Mahi Mahi, and Wahoo. An evaluation of Trinidad Dock & Fishing Services Ltd.'s HACCP plan for these products demonstrated serious deviations from the United States' Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation, 21 CFR Part 123. Specifically, the firm's HACCP plan failed to include critical control points as required by 21 CFR 123.6(a) and (c)(2). The identified deficiencies include the absence of a critical control point for the receipt of fish from harvest vessels to control histamine development, and the lack of a critical control point for "Storage" to ensure proper packing and temperature control prior to distribution. These omissions render the firm's fishery products adulterated under Section 402(a)(4) of the U.S. Federal Food, Drug and Cosmetic Act. The FDA requires a written response within fifteen working days outlining specific corrective actions, including revised HACCP plans and verification records. Failure to adequately respond may result in further action, such as refusal of admission and detention without physical examination (DWPE) of imported products under Section 801(a) of the Act, potentially through Import Alert #16-120. The firm is responsible for ensuring compliance with all applicable regulations.