FDA WARNING_LETTER - Greencore USA, LLC - June 12, 2012

On October 17, 2012, the FDA issued a Warning Letter to Greencore USA, LLC, following an inspection of their ready-to-eat (RTE) sandwich manufacturing facility in Newburyport, MA, from June 4-12, 2012.

The inspection revealed the presence of *Listeria monocytogenes* (L. monocytogenes), a human pathogen, in environmental samples, including food contact surfaces where seafood sandwiches are prepared. Specific positive samples were found on a conveyor belt, the underside of a metal jacket, and a production table. This finding, coupled with observed violations of Current Good Manufacturing Practice (CGMP) (21 CFR Part 110) and seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123), led the FDA to determine that the RTE seafood sandwiches were adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The letter emphasized the importance of identifying and controlling *L. monocytogenes* niche areas, noting that the firm failed to adequately clean food contact surfaces as required by 21 CFR 110.35(a) and (d) and 21 CFR 123.11(b). The FDA also noted previous *L. monocytogenes* findings during a January 2011 inspection, which led