FDA WARNING_LETTER - Caito Fisheries Inc - September 04, 2012

The FDA inspected Caito Fisheries, Inc.'s seafood processing facility in San Francisco, CA, from August 22 to September 4, 2012, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). This renders their seafood products, including fresh, refrigerated scombroid finfish Albacore Tuna, fresh, refrigerated raw Dungeness Crab, and refrigerated, ready-to-eat cooked Dungeness Crab, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

The firm's September 25, 2012, response to the FDA 483 was inadequate due to incomplete HACCP plans. Significant violations include: 1. Failure to have a HACCP plan for receiving and storing ready-to-eat cooked Dungeness Crab to control pathogen growth and toxin formation (21 CFR 123.6(a) and (b)). 2. HACCP plans for Albacore Tuna and Dungeness Crab do not list undeclared allergens as a food safety hazard (21 CFR 123.6(a) and (c)(1)). 3. HACCP plans for Dungeness Crab and Fresh Albacore Tuna do not list "Finished Product Storage" as a critical control