FDA WARNING_LETTER - Yandi New York Trading Co Ltd - June 20, 2014

On June 18-20, 2014, the FDA inspected Yandi New York Trading Co Ltd's seafood importer establishment. 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, concerning imported fish and fishery products.

The primary violation identified was the firm's failure to implement an affirmative step to ensure that imported dried anchovy product, manufactured by (b)(4), was processed in accordance with the seafood HACCP Regulation, as required by 21 CFR 123.12(a)(2)(ii). This renders the dried anchovy product adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), as it was prepared, packed, or held under insanitary conditions.

The firm's written response to the FDA 483, submitted on June 23, 2014, including a Certificate of HACCP Compliance, was reviewed. However, the implemented affirmative step was deemed insufficient, as it did not provide an equivalent level of assurance that the anchovies complied with FDA seafood HACCP regulations.

Failure to promptly correct these violations may result in further FDA action, including refusal of admission of imported