FDA WARNING_LETTER - Sinosharp Import & Export Co Ltd - April 26, 2017

On April 25 and 26, 2017, the FDA inspected Sinosharp Import & Export Co. Ltd. and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. As an importer, Sinosharp must ensure imported fish and fishery products comply with 21 CFR Part 123.

The significant violation identified was the failure to implement an affirmative step to ensure imported ready-to-eat baked codfish fillets, intended for ambient temperature distribution, were processed in accordance with the seafood HACCP Regulation, as required by 21 CFR 123.12(a)(2)(ii). This renders the product adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Sinosharp's May 1, 2017, response to the FDA 483 was deemed inadequate because the provided HACCP Verification Certificate from CNCA did not list cod or baked cod fillets among the covered products.

Failure to correct these violations may result in refusal of admission for imported products under Section 801(a) of the Act, including "detention without physical examination," product seizure, and/or injunction. Sinosharp must respond in writing within fifteen working days, outlining specific corrective actions, including documentation of corrected HACCP and importer verification