Donlan Fish & Seafoods, Inc. – FDA Warning Letter, Mar 7, 2013

On March 29, 2013, the FDA issued a Warning Letter to Donlan Fish and Seafoods, Inc. following an inspection from February 27 to March 7, 2013. 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).

The FDA determined that the firm's seafood products, including ready-to-eat (RTE) refrigerated pasteurized crabmeat and fresh whitefish fillet products, were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Lack of HACCP Plan:** The firm failed to conduct a hazard analysis and implement a written HACCP plan for RTE refrigerated pasteurized crabmeat to control pathogen growth, violating 21 CFR 123.6(a) and (b). 2. **Insufficient Sanitation Monitoring:** The firm did not monitor sanitation conditions and practices with sufficient frequency to ensure compliance with CGMP requirements (21 CFR 123.11(b)). Specific deficiencies included: * Absence of backflow prevention devices and direct sewage connection for a sink.