FDA WARNING_LETTER - Pacific Fishing Company Limited - October 20, 2010

On October 20, 2010, the FDA issued a Warning Letter to Pacific Fishing Company Limited based on an evaluation of their HACCP plan and supporting documents for tuna loins, submitted between June 4-6, 2010. The FDA found serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their tuna loins adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis and CCPs:** The HACCP plan for "Tuna Loins" failed to list critical control points at the pre-cook operation or subsequent steps to control scombrotoxin formation, as required by 21 CFR 123.6(a) and (c)(2). The plan incorrectly suggested scombrotoxin concerns ended at the staging operation. 2. **Inappropriate Corrective Actions:** The HACCP plan listed inappropriate corrective actions at the "Receiving of frozen fish" CCP (CCP 1a), violating 21 CFR 123.7(b).

Additional concerns were noted regarding: * **Histamine Sampling:** The firm's monitoring procedures for "Receiving of frozen fish" (CCP 1a) specified sampling the "nape" of the fish, which FDA studies