FDA WARNING_LETTER - Ocean Beauty Seafoods, Inc. - June 26, 2008

On June 25-26, 2008, the FDA inspected a seafood processing facility at 1100 W. Ewing Street, Seattle, Washington, and found 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). The firm's pouched, refrigerated, pasteurized crab meat and fresh scombroid species products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations include: 1. **Lack of HACCP Plan:** The firm failed to have a HACCP plan for pouched, refrigerated, pasteurized crabmeat to control *Clostridium botulinum*, despite claiming to have completed and implemented one in a July 3, 2008, response. A subsequent September 17, 2008, response did not provide the requested plan or monitoring records. 2. **Inappropriate Corrective Actions:** The HACCP plan for fresh scombroid species had inappropriate corrective actions for "Storage" critical control points. The listed action ("If core temperature reached (b)(4) deg. F for no more than (b)(4) , then isolate, ice adequately and monitor temp....") is impractical given the firm's monitoring frequency