FDA WARNING_LETTER - First Choice E Trading Corp. - June 08, 2017

The FDA issued a Warning Letter to First Choice E Trading Corp. on November 22, 2017, following an inspection on June 8, 2017, at their seafood importer establishment in Flushing, NY. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically concerning imported fish and fishery products under 21 CFR 123.12. The primary violation identified was the firm's failure to implement an affirmative step to ensure that imported frozen bigeye tuna, Thunnus obesus, was processed in accordance with the seafood HACCP Regulation, as required by 21 CFR 123.12(a)(2)(ii). This deficiency renders the product adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The firm's submitted response to the FDA 483 was deemed inadequate, as the provided documentation did not assure compliance. The FDA requires a written response within fifteen working days, detailing specific corrective actions, including corrected HACCP and importer verification records, and documentation of affirmative steps. Failure to correct these violations may lead to further actions, such as refusal of admission (including detention without physical examination) under Section 801(a) of the Act, product seizure, injunction, and assessment of re-inspection fees. The letter emphasizes the firm's responsibility to operate in compliance with the Act and all applicable regulations.