Russian Products, Inc. – FDA Warning Letter, Jan 24, 2014

An FDA inspection of Russian Products, Inc., a seafood importer, conducted on January 23-24, 2014, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Specifically, the firm failed to implement an affirmative step to ensure that imported herring fillets in oil were processed in accordance with 21 CFR 123.12(a)(2)(ii). This deficiency led to the adulteration of the firm's herring fillets in oil under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), as they were prepared, packed, or held under insanitary conditions. Furthermore, a specific entry of herring fillets in oil (entry (b)(4)) was found adulterated under Section 402(a)(1) of the Act, following FDA laboratory analysis that detected (b)(4) in the product. The FDA mandates that importers provide evidence that all fish and fishery products comply with 21 CFR Part 123, otherwise, products are considered adulterated and denied entry. Russian Products, Inc. must respond in writing within fifteen working days, detailing specific corrective actions, including HACCP and importer verification records. Failure to promptly correct these violations may result in refusal of admission, detention without physical examination, product seizure, injunction, and assessment of re-inspection fees.