FDA WARNING_LETTER - Advanced Foods - May 29, 2013

On May 7-29, 2013, the FDA inspected Advanced Foods, Inc. in Westbury, NY, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). As an importer, the firm is required by 21 CFR 123.12(a)(2) to have and implement written verification procedures, including product specifications and an affirmative step, to ensure imported fish and fishery products are processed according to Part 123.

The inspection revealed that Advanced Foods, Inc. had no written verification procedures and did not implement an affirmative step for imported frozen seafood products, including arrow tooth flounder, squid, whelk, breaded shrimp, and tilapia. This renders their imported products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

The FDA warned that failure to promptly correct these violations could lead to further action, such as product seizure and/or injunction against the firm's operation. Advanced Foods, Inc. was required to respond in writing within fifteen working days, outlining specific corrective actions and providing supporting documentation. The letter also noted that the firm is responsible for ensuring compliance with the Act, seafood HACCP, and Current Good Manufacturing Practice regulations, and may be assessed re-inspection fees for non-compliance related