FDA WARNING_LETTER - Seapak O.C.I. - June 22, 2012

On June 21-22, 2012, the FDA inspected Seapak O.C.I.'s seafood processing facility in Masset, Canada, identifying serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The inspection resulted in an FDA-483, and despite the firm's July 6, 2012, response with corrective actions and revised HACCP plans, concerns persist.

The FDA determined that the firm's frozen vacuum-packed raw salmon and halibut fillets, and hot and cold smoked fish fillets are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under conditions that may render them injurious to health.

Key violations include: 1. **Failure to conduct adequate hazard analysis (21 CFR 123.6(a) and (c)(1)):** * The HACCP plan for frozen vacuum-packed raw fish did not identify *Clostridium botulinum* as a hazard during vacuum-packaged product holding before freezing, where toxin formation is likely without strict temperature control (recommended <3.3°C). * The HACCP plan for cold smoked fish failed to identify parasites as a hazard in ready-to-eat products, despite referencing them in the hazard analysis worksheet