Seafood Brothers Inc., DBA G & L Seafood Inc. – FDA Warning Letter, Mar 23, 2023

On May 18, 2023, the FDA issued a Warning Letter to 2416 Chico Avenue, South El Monte, CA, following a March 23, 2023, inspection. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), specifically concerning imported frozen whole cooked white clams, frozen whole clean headless white anchovies from Vietnam, and frozen whole aquaculture tilapia from Taiwan. These products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to have and implement written verification procedures, product specifications, and an affirmative step to ensure imported fish and fishery products comply with Seafood HACCP (21 CFR 123.12(a)(2)). This was noted for anchovies and clams, and for tilapia, where a written guarantee from the foreign processor was missing despite having their HACCP plan. 2. Lack of evidence that imported fish were processed under compliant conditions (21 CFR 123.12(d)). For tilapia, product specifications did not include parasite hazards or specific aquaculture drug and chemical hazard tolerance levels. 3. Records not including dates, times, and signatures/initials of the person performing the operation (21 CFR 123.9(a)),