Aramark Healthcare Albany Production Center – FDA Warning Letter, Jun 6, 2011

On September 12, 2011, the FDA issued a Warning Letter to Aramark Inc. following an inspection of their seafood processing facility in Albany, New York, from June 1 to June 6, 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 was the firm's failure to have and implement written HACCP plans for several products, as required by 21 CFR 123.6(a) and (b). Specifically, no HACCP plans existed for: * Ready-to-eat Tuna Salad, to control scombrotoxin formation (histamine) and pathogen growth/toxin formation (including *Clostridium botulinum*) due to time/temperature abuse. * Nantucket Baked Fish (breaded cod), to control pathogen growth, pathogen survival through cooking/pasteurization, and toxin formation (including *Clostridium botulinum*) due to time/temperature abuse. * Manhattan Clam Chowder, to control pathogen growth, pathogen survival through cooking/pasteurization, and toxin formation (including *Clostridium botulinum*) due to time/temperature abuse.

These omissions render the listed products adulterated under Section 402(