FDA WARNING_LETTER - Fish Busterz, L.L.C. - April 30, 2014

An FDA inspection of Fish Busterz L.L.C. in Stock Island, FL, conducted on April 29-30, 2014, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). Consequently, the firm's fresh King Mackerel is deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include the failure to conduct a proper hazard analysis and list all reasonably likely food safety hazards, such as Ciguatera Fish Poisoning and allergens, in the HACCP plan for King Mackerel (21 CFR 123.6(a) and (c)(1)). The firm also lacked adequate critical limits in its HACCP plan to control Scombrotoxin (Histamine) Formation, particularly as a primary processor receiving fish directly from harvest vessels (21 CFR 123.6(c)(3)). Furthermore, the firm failed to implement the monitoring procedures and frequencies listed in its HACCP plan for Scombrotoxin Formation at receiving and storage critical control points (21 CFR 123.6(b) and (c)(4)), including not checking harvest vessel ice conditions or ice levels during storage. Notably, the critical limit and monitoring procedure violations are repeat observations from previous FDA 483s and Warning Letters. The firm is required to respond in writing within fifteen working days, detailing corrective actions and providing supporting documentation. Failure to comply may result in re-inspection fees, and the firm is responsible for ensuring overall compliance with all applicable regulations.