FDA WARNING_LETTER - Supreme Seafood, LLC - July 14, 2008

On July 11 and 14, 2008, the FDA inspected a seafood importer establishment at 272 Dick George Road, Cave Junction, Oregon, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Specifically, the firm failed to maintain English records documenting the performance and results of affirmative steps, as required by 21 CFR 123.12(c), for rock fish, sole, and ling cod fillets processed by (b)(4) and (b)(4) Canada.

As an importer, the firm must ensure all imported fish and fishery products comply with 21 CFR Part 123. Without such assurances, products appear adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), and will be denied entry. The identified violations render the firm's fresh and frozen seafood products, including rock fish, sole, and ling cod, adulterated because they were prepared, packed, or held under insanitary conditions.

The firm is also required by 21 CFR 123.12 to have written verification procedures outlining an affirmative step to ensure imported products comply with HACCP regulations and include product specifications to prevent injury to health. Failure to