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

Source: https://www.keypedia.com/records/warning_letter/great-american-marketing-company/df84b2fa-b04c-46e9-ace8-6f8806abe94c

> FDA WARNING_LETTER for Great American Marketing Company on August 04, 2017. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Great American Marketing Company
- Inspection Date: 2017-08-04
- Product Type: Food
- Office Name: Dallas District Office
- Summary: 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.

## Related Officers

- [Jamie M. Bumpas](https://www.keypedia.com/people/jamie-m-bumpas/5b93e99d-1018-40c1-bfa7-9f129dd22cf4)
- [Program Director](https://www.keypedia.com/people/edmundo-garcia/d47fc6d7-1ed9-4a65-bcaf-b3860041ca55)

Company: https://www.keypedia.com/companies/great-american-marketing-company/2e463515-20d6-490e-8464-0b01aa55c986

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9