FDA WARNING_LETTER - DZH Import & Export Inc. - December 22, 2014

On December 22, 2014, the FDA inspected DZH Import & Export Inc.'s seafood importer establishment at 1300 Metropolitan Avenue, Brooklyn, 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 that imported fish and fishery products are processed in accordance with the seafood HACCP Regulation, as required by 21 CFR 123.12(a)(2)(ii). Specifically, DZH Import & Export Inc. did not perform an affirmative step for their dried baby anchovies manufactured by (b)(4) in (b)(4).

This violation means the dried baby anchovies are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), as they were prepared, packed, or held under insanitary conditions that may render them 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.