FDA WARNING_LETTER - Galveston Shrimp & Fish Company, Inc. - June 12, 2008

On June 6, 10-12, 2008, the FDA inspected Galveston Shrimp & Fish Company, Inc. and found serious violations of 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 wahoo, amberjack, grouper, and snapper products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include inadequate critical limits in HACCP plans for "Wahoo," "Fish (Amberjack, Black Drum, Sheephead, Tuna, Mahi Mahi)," and "Snapper" at the receiving critical control points. Specifically, the plans failed to adequately control histamine formation in Wahoo, Amberjack, Tuna, and Mahi Mahi, and ciguatera toxin (CFP) in Snapper. The firm's HACCP plan for "Wahoo" lacked specific temperature or time critical limit values for receiving, and purchase orders were insufficient to ensure histamine control during transit. For "Fish," monitoring procedures for secondary processors did not align with critical limits, and for "Snapper," pen and ink changes for CFP control were inadequate as they did not address monitoring harvest areas.

Additionally, the HACCP plan for "Grouper" and "Fish" (including Amberjack) failed to list