FDA WARNING_LETTER - Capitol Food Services d.b.a Double A Provisions LLC - August 08, 2011

On September 16, 2011, the FDA issued a Warning Letter to Capitol Food Services d.b.a. Double A Provisions LLC following an inspection of their seafood processing facility in Queensbury, New York, on August 5 and 8, 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 regulation for foods (21 CFR Part 110).

The primary violation cited was the firm's failure to conduct a hazard analysis and implement written HACCP plans for several seafood products, including canned pasteurized crabmeat, mahi fillets, seafood salad, smoked salmon, and tuna salad. Specifically, the firm lacked HACCP plans to control pathogen growth and toxin formation for all listed products, and scombrotoxin formation for mahi fillets and tuna salad. This renders the affected products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

The FDA stated that failure to promptly correct these violations could lead to further action, including product seizure and/or injunction against the firm's operation. Capitol Food Services was required to respond in writing within fifteen working days, outlining specific corrective actions, including documentation such as HACCP and verification records. The letter also noted that it might