FDA WARNING_LETTER - Greencore OARS, LLC - October 20, 2011

The FDA inspected Greencore OARS, LLC's ready-to-eat (RTE) sandwich manufacturing facility in Brockton, MA, between February and March 2011, and again in September and October 2011. Environmental swabs and finished RTE tuna fish sandwich samples collected during these inspections tested positive for *Listeria monocytogenes*. The presence of *L. monocytogenes* in finished product renders the food adulterated under Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

The firm also had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110). Specific violations included failure to monitor sanitation conditions and practices with sufficient frequency, as evidenced by pooling water on the production room floor and condensate above tuna sandwich processing lines. Additionally, the firm failed to manufacture, package, and store foods under conditions to minimize microbial growth and contamination, as indicated by the *L. monocytogenes* findings.

The FDA found the firm's October 25, 2011, response unacceptable, noting it lacked sufficient corrective actions, focused only on tuna fish manufacturing, and did not address the root cause of deficiencies. The FDA recommended a comprehensive assessment of all manufacturing operations and products to determine the root cause