FDA WARNING_LETTER - Blue Water Connection Seafood Corp. - August 01, 2011

The FDA inspected Blue Water Connection Seafood Corp. in Hialeah, FL, from July 25 to August 1, 2011, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render the firm's pasteurized crab meat, fresh crab meat, swordfish, grouper, and tuna adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plans:** The firm lacks written HACCP plans for canned pasteurized crab meat (to control *Clostridium botulinum* and undeclared allergens), fresh crab meat (to control pathogen growth, toxin formation, and undeclared allergens), and swordfish and grouper (to control undeclared allergens). 2. **Failure to Implement Monitoring Procedures:** The firm did not follow monitoring procedures at receiving and storage Critical Control Points (CCPs) for "Fresh Tuna, Mahi-Mahi, and Snapper" to control histamine formation. Specifically, cooler temperature and ice adequacy were not sufficiently monitored since August 2009, with observations on July 25, 2011, showing a cooler temperature of 67.5°F and tuna at 61.5°F without adequate ice. Receiving CCP monitoring for ice amount and