Douty Brothers, Inc. – FDA Warning Letter, Dec 30, 2011

On January 23, 2012, the FDA issued a Warning Letter to Douty Brothers, Inc. following an inspection from December 13-30, 2011. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice (CGMP) regulation for foods (21 CFR Part 110). These violations render the firm's ready-to-eat (RTE) seafood products, including refrigerated RTE lobstermeat and RTE fluke, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plan:** The firm did not have a HACCP plan for RTE fluke to control hazards like parasites, pathogen growth, and toxin formation (21 CFR 123.6(a) and (b)). The firm stated they would no longer handle fresh fluke. 2. **Failure to Implement Monitoring Procedures:** The firm did not follow monitoring procedures in their "Lobster Meat" HACCP plan. They failed to take internal temperatures of lobster meat during cooking and did not check ice adequacy for cooked lobster meat twice daily as specified (21 CFR 123.6(b) and (c)(4)). 3. **Inadequate Record