FDA WARNING_LETTER - Gulf Shrimp Co. LLC - January 23, 2014

On January 15-23, 2014, an FDA inspection of Gulf Shrimp Co., LLC's seafood processing facility 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 refrigerated smoked seafood, canned pasteurized crab meat, and histamine-forming finfish, including tuna loins, are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations included the failure to have a HACCP plan that lists adequate monitoring procedures and frequencies for critical control points (21 CFR 123.6(c)(4)), particularly for Clostridium botulinum toxin formation and pathogen growth at receiving. The firm also failed to implement the record-keeping system listed in its HACCP plan (21 CFR 123.6(b) and (c)(7)), as evidenced by missing data logger records for cooler storage temperatures. Additionally, the firm's corrective action plans were found to be inappropriate (21 CFR 123.7(b)), lacking procedures to investigate root causes of deviations and ensure affected products are not distributed. The FDA noted a potential typographical error in critical limits within the HACCP plans. The firm was instructed to respond within fifteen working days, outlining specific corrections with supporting documentation, and was warned of potential further actions such as product seizure, injunction, and re-inspection fees if violations are not promptly corrected.