FDA WARNING_LETTER - Seoul Shopping, Inc - February 04, 2008

On January 31 and February 4, 2008, the FDA inspected Seoul Shopping, Inc. dba HanYang Super Market, a seafood importer in Flushing, NY. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically 21 CFR 123.12, which governs imported fish and fishery products.

The primary violation identified was the firm's failure to implement an affirmative step to ensure imported fish and fishery products are processed in accordance with seafood HACCP regulations, as required by 21 CFR 123.12(a)(2)(4). This deficiency was noted for Squid, Seasoned Sprat, Oyster, and Salted Anchovy from various manufacturers. As a result, these products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), meaning they were prepared, packed, or held under insanitary conditions potentially injurious to health.

The FDA warns that failure to promptly correct these violations may lead to further action, including refusal of admission of imported products under Section 801(a) of the Act (21 U.S.C. § 381(a)), "detention without physical examination," product seizure, and