FDA WARNING_LETTER - peter bacle - May 02, 2014

The FDA inspected Stock Island Lobster Company in Key West, Florida, on May 1-2, 2014, identifying serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice regulations (21 CFR Part 110). Consequently, the firm's fresh King Mackerel was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Key violations included the King Mackerel HACCP plan lacking a "Packaging" critical control point for the "Allergen" hazard (21 CFR 123.6(c)(2)) and an inadequate critical limit at receiving to control Scombrotoxin (Histamine) Formation (21 CFR 123.6(c)(3)). The firm also failed to implement monitoring procedures for King Mackerel at receiving for ciguatoxin and at receiving/storage for histamine formation due to time/temperature abuse (21 CFR 123.6(b) and (c)(4)), including inadequate ice monitoring, a repeat observation. Furthermore, the firm failed to verify the adequacy of its HACCP plan's critical limits for King Mackerel regarding ciguatoxin and scombrotoxin/histamine control (21 CFR 123.8(a)), with issues in reviewing harvest records, sensory examination records, temperature records, and monitoring activity records. The firm must respond in writing within fifteen working days, detailing specific corrective actions and providing supporting documentation. They are responsible for ensuring full compliance with all applicable regulations and preventing future violations.