FDA WARNING_LETTER - Best Choice Trading Corp. - February 20, 2014

On February 12-20, 2014, the FDA inspected Best Choice Trading Corp., a seafood importer, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Specifically, the firm failed to implement an affirmative step to ensure imported fish and fishery products are processed in accordance with HACCP, as required by 21 CFR 123.12(a)(2)(ii).

This deficiency was identified in relation to frozen vacuum-packed raw ground tuna meat (Thunnus Albacares) from a specific manufacturer. An FDA sample of this product, imported under entry number (b)(4) on October 28, 2013, was found to be adulterated due to decomposition, leading to its refusal of admission on November 27, 2013.

The FDA stated that the firm's frozen vacuum-packed raw ground tuna meat is adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) because it was prepared, packed, or held under insanitary conditions. The letter warns of potential further actions, including refusal of admission, detention without physical examination, seizure, and injunction.

Best Choice Trading Corp. must respond in writing within fifteen working days, outlining specific corrective actions, including documentation of corrected HACCP and importer verification records,