Cape Florida Seafood, Inc. – FDA Warning Letter, Jun 1, 2012

On August 22, 2012, the FDA issued a Warning Letter to Cape Florida Seafood, Inc. following an inspection from May 23 to June 1, 2012. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their tuna, salmon, and pasteurized crab meat products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis:** The HACCP plan for Fresh Histamine Producing Fish failed to list pathogenic bacteria growth and toxin formation (other than Clostridium botulinum) from time and temperature abuse at the Processing/Butchering critical control point, despite acknowledging that fresh tuna may be eaten uncooked. (21 CFR 123.6(c)(1)) 2. **Missing Critical Limits:** The HACCP plan for Pasteurized Crab Meat listed an insufficient critical limit at the Receiving CCP, failing to specify the temperature throughout transportation to control Clostridium botulinum toxin formation and pathogenic bacteria growth. (21 CFR 123.6(c)(3)) 3. **Insufficient Monitoring Procedures:** * HACCP plans for histamine-producing fish and pasteurized crab meat had inadequate monitoring procedures and frequencies at receiving and storage CCPs. Visual checks