FDA WARNING_LETTER - One Chang Corp. - September 03, 2015

On September 3, 2015, the FDA inspected One Chang Trading Inc.'s seafood importer establishment in Brooklyn, NY, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). As an importer, One Chang Trading Inc. must ensure all imported fish and fishery products comply with 21 CFR Part 123.

The primary violation identified was the failure to implement an affirmative step to ensure that imported frozen dried anchovy, from a specific exporter, was processed in accordance with the seafood HACCP Regulation, as required by 21 CFR 123.12(a)(2)(ii). This renders the frozen dried anchovy 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 that may render it injurious to health.

Failure to correct these violations may result in further FDA action, including refusal of admission of imported products under Section 801(a) of the Act, detention without physical examination, product seizure, and/or injunctions. The company must respond in writing within fifteen working days, outlining specific corrective actions, including documentation of HACCP and importer verification records, and performance results of affirmative steps. Delays must be explained