April 6, 2020

FDA Warning Letter Sent to TX Country Fresh Over Listeria Findings

The FDA has sent a warning letter to Country Fresh of Spring, Texas, about Listeria monocytogenes that was found in their facility that produces fresh, ready-to-eat produce. Inspections of the facility “found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP and PC Rule), Title 21, Code of Federal Regulations (CFR), Part 117 (21 CFR Part 117),” according to the letter.

FDA Warning Letter Sent to TX Country Fresh Over Listeria Findings

Inspectors took swabs of the environment, including areas near food processing operations, and found Listeria monocytogenes. That means that the ready-to-eat products are adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act. No illnesses have been reported in connection with any Country Fresh products.

The FDA issued FDA-483, that lists deviations from good manufacturing practices found during the inspection. While the firm responded to these findings, they did not provide supporting documentation of the corrective actions according to the FDA.

In addition, a retail product sample of watermelon spears that was collected at a WalMart store on May 9, 2019 by the FDA tested positive for Listeria monocytogenes bacteria. That product was made at the Country Fresh location in Grand Prairie, Texas. Whole genome sequencing of that sample showed that it matched an environmental sample collected by the state of Texas in 2013 at the Country Fresh location in Houston, Texas, and historical clinical isolates.

Once Listeria monocytogenes is established in a location, it can be very difficult to eradicate. The pathogen can form biofilms that protects it against cleaners and cleaning efforts. The company has 15 days to respond to this letter, providing supporting documentation and implementing corrective actions.

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