ocean group inc. ( – FDA Warning Letter, Jul 12, 2011

On November 9, 2011, the FDA issued a Warning Letter to Ocean Group Inc. DBA Ocean Fresh Fish & Seafood Marketing following an inspection from July 5-12, 2011. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). These violations render the firm's fish and fishery products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plans:** The firm's revised HACCP plans for "fresh tuna" and "fresh aquaculture salmon" failed to identify the hazard of pathogens at the Receiving critical control point. All revised HACCP plans, including those for "fresh vacuumed imitation crab meat, fresh vacuumed yellowtail hamachi, and canned pasteurized blue crab meat," failed to identify the hazard of undeclared allergens. 2. **Failure to Implement Affirmative Steps for Imports:** The firm did not implement affirmative steps to ensure imported Jack Mackerel from Japan, fresh whole Atlantic salmon from Canada, and fresh salmon from the United Kingdom were processed according to FDA's seafood HACCP regulations. 3. **Inadequate Monitoring Procedures:** The HACCP plan for fresh raw ready-to-eat