Han Sung Sikpoom Trading Co. – FDA Warning Letter, Jan 10, 2014

On January 9-10, 2014, the FDA inspected Han Sung Sikpoom Trading Co., a seafood importer, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), specifically 21 CFR 123.12 for imported fish and fishery products.

The primary violation was the firm's failure to implement an affirmative step to ensure imported dried filefish, manufactured by (b)(4), was processed in accordance with the seafood HACCP Regulation, as required by 21 CFR 123.12(a)(2)(ii). An FDA sample of this dried filefish, entry number (b)(4), collected on (b)(4), was found to contain (b)(4) and was refused admission on (b)(4).

This rendered the dried filefish adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)) because it was prepared, packed, or held under insanitary conditions. The product was also adulterated under Section 402(a)(1) of the Act (21 U.S.C. § 342(a)(1)) due to the laboratory finding.

The FDA warned of further actions, including refusing admission of