Great American Marketing Company – FDA Warning Letter, Aug 4, 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.