Russell Hall Seafood, Inc. – FDA Warning Letter, Jul 10, 2013

On July 31, 2013, the FDA issued a Warning Letter to Russell Hall Seafood, Inc. following an inspection on July 1, 2, and 10, 2013. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering 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. Lack of a HACCP-trained individual (21 CFR 123.10). 2. Failure to conduct a hazard analysis and implement a written HACCP plan for bluefish to control histamine formation, and deficiencies in the "Fresh Crabmeat; non-hermetic cups" HACCP plan, including inadequate monitoring of ice presence/absence and lack of continuous recording equipment for the cook step (21 CFR 123.6(b) and (c)). 3. Failure to adequately monitor sanitation conditions, with observations of employees using a portable toilet without handwashing facilities, lack of chlorine in a shovel dip, and presence of insects in the crab picking room (21 CFR 123.11(b)). 4. Failure to maintain sanitation control records outside of blue crab season (21 CFR 123.11(