FDA WARNING_LETTER - Great American Marketing Company - August 04, 2017

The FDA inspected Great American Marketing Company's RTE manufacturing facility in Houston, Texas, from July 24 to August 4, 2017. The inspection revealed the presence of *Listeria monocytogenes* (L. monocytogenes), a human pathogen, in environmental samples, including direct food contact surfaces. This led to the determination that RTE products like Ham & Cheddar Sandwich and Turkey & Swiss Sandwich were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

FDA's analysis confirmed six environmental swabs were positive for *L. monocytogenes*, with three from direct food contact surfaces (conveyor belt attachment, seam, and top of conveyor belt) where sandwiches were assembled. Whole-Genome Sequencing (WGS) identified one strain of *L. monocytogenes* identical to strains found in the facility in 2016 and in a USDA sample from 2014, indicating a persistent presence. The presence of non-pathogenic *Listeria* species also suggested conditions suitable for *L. monocytogenes* growth.

Additionally, a significant cGMP violation was observed: condensate dripping from the ceiling onto the production room floor, violating 21 CFR 110.20(b)(4). The firm's August 22, 2017, response stated covering affected areas with plastic sheets and evaluating long-term solutions.