jin han international, inc. ( – FDA Warning Letter, Aug 15, 2013

On September 25, 2013, the FDA issued a Warning Letter to Mr. Suk M. Bae, c/o Jin Han International, Inc. (dba Pacific Foods Co.), following an inspection of their seafood importer establishment in Commerce, CA, from August 6 to August 15, 2013. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically concerning imported fish and fishery products under 21 CFR 123.12.

The FDA found that the firm's canned Mackerel Pike, canned Mackerel, and canned Bai-Top Shell were adulterated 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.

Key violations included: 1. Failure to implement an affirmative step to ensure imported fish and fishery products are processed in accordance with 21 CFR 123.12(a)(2)(ii). Specifically, no affirmative step was in place for the aforementioned canned products manufactured by (b)(4). 2. Failure to comply with 21 CFR 123.12(a)(2)(i) by not having product specifications designed to ensure imported fish and fishery products are not injurious to health or processed under insan