FDA WARNING_LETTER - Lighthouse Marina Partnership - June 01, 2010

On May 26-June 1, 2010, the FDA inspected Lighthouse Marina Partnership's seafood processing facility, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). These violations render the firm's tuna, bonito, and bluefish adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to implement monitoring procedures (21 CFR 123.6(b) and (c)(4)):** The firm did not consistently follow its HACCP plan for "receive fish from harvest vessel" to control histamine formation. Specifically, internal temperatures were not taken on a representative number of fish, sensory evaluations for decomposition were not consistently performed, and harvest vessel records lacked crucial information like cooling rates, time cooling began, and ice adequacy. Out of 13 processing dates reviewed, only five had receiving records, and even these were incomplete regarding sensory evaluation and estimated time of death. 2. **Inappropriate corrective action (21 CFR 123.7(b)):** The HACCP plan's corrective action for scombrotoxin formation at the storage critical control point, "add ice," is deemed inappropriate as it does not ensure adulterated product is prevented from entering commerce. The FDA recommends histamine testing on a minimum of 60 fish