FDA WARNING_LETTER - Fells Point Wholesale Meats, Inc. - December 08, 2011

On February 24, 2012, the FDA issued a Warning Letter to Fells Point Wholesale Meats, Inc. following an inspection of their pet food manufacturing and seafood warehouse facility from December 5-8, 2011. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their seafood products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plans:** The firm failed to conduct a hazard analysis and implement written HACCP plans for seafood products like pasteurized swimming crabmeat, vacuum-packed smoked salmon, and pickled herring, to control hazards such as pathogen growth and toxin formation from time/temperature abuse (21 CFR 123.6(a) and (b)). 2. **Inadequate Sanitation Monitoring:** The firm did not sufficiently monitor sanitation conditions and practices to ensure compliance with Current Good Manufacturing Practice (CGMP) requirements (21 CFR 110 and 21 CFR 123.11(b)). Specific observations included: * Apparent meat, fat, and dried blood in the men's bathroom handwashing sink. * Sanitation records lacking observations on proper labeling, storage, and use of toxic compounds. *