FDA WARNING_LETTER - Sysco Food Services of Albany, LLC - February 15, 2008

An FDA inspection of Sysco Food Services of Albany, LLC, conducted on February 11, 13, and 15, 2008, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). Consequently, the firm's refrigerated, ready-to-eat seafood and tuna salads are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key deficiencies include the failure to implement monitoring procedures and frequencies as listed in the HACCP plan for ready-to-eat seafood products at the receiving critical control point, specifically regarding time/temperature recorders and inappropriate monitoring of cooling media (21 CFR 123.6(b)). The firm also failed to conduct a proper hazard analysis for refrigerated tuna salad, omitting scombrotoxin formation as a reasonably likely food safety hazard (21 CFR 123.6(a) and (c)(l)). Furthermore, the corrective action plan for controlling pathogen growth/toxin formation at the storage critical control point was deemed inappropriate, lacking clarity on product discard and having an insufficient monitoring frequency (21 CFR 123.7(b)). The FDA requires a written response within fifteen working days outlining specific corrective actions, supported by documentation, and an explanation for any delays. Failure to correct these violations may result in further action, including product seizure or injunction.