FDA WARNING_LETTER - Jh Seafood Supply Inc - July 08, 2015

On July 8, 2015, the FDA inspected Jh Seafood Supply Inc. and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically 21 CFR 123.12, concerning imported fish and fishery products. The firm's frozen shrimp was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The primary violation was the failure to implement an adequate affirmative step to ensure imported frozen, raw, aquacultured shrimp from Malaysia, processed by (b)(4), complied with seafood HACCP regulations (21 CFR 123.12(a)(2)(ii)). The firm's July 10, 2015, response to FDA Form 483 was inadequate because: 1. The submitted HACCP plan for "RAW FROZEN CULTURED PRAWNS/SHRIMPS" from (b)(4) did not identify aquaculture drugs or sulfites as hazards. 2. Written guarantees from (b)(4) did not state that imported seafood products complied with 21 CFR 123. 3. No affirmative step was identified for raw, frozen aquacultured shrimp from (b)(4) from Malaysia.

Failure to correct these violations may result in refusal of admission, "Detention Without Physical