FDA WARNING_LETTER - American Seaway Foods - April 17, 2013

On April 3-17, 2013, the FDA inspected American Seaway Foods' seafood warehouse, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render their refrigerated seafood products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The firm's May 6, 2013, response was deemed inadequate.

Key violations include: 1. Failure to have a HACCP plan for refrigerated, raw canned scallops (21 CFR 123.6(a) and (b)). 2. HACCP plans for ready-to-eat pasteurized crabmeat, sushi, and tuna salad do not list all reasonably likely food safety hazards, specifically *Clostridium botulinum* toxin formation and pathogen growth/toxin formation (21 CFR 123.6(a) and (c)(1)). 3. HACCP plans for sushi, ready-to-eat tuna salad, fresh tuna/marlin/mackerel, ready-to-eat pasteurized crabmeat, and ready-to-eat seafood salads have inadequate critical limits at the receiving critical control point for scombrotoxin (histamine) formation and pathogen growth/toxin formation (21 CFR 123.6(c)(3)).