Country Fresh Inc. – FDA Warning Letter, Jul 17, 2019

The FDA inspected Country Fresh's RTE fresh cut produce facility in Grand Prairie, TX, from July 9-17, 2019, finding serious violations of the CGMP and PC Rule (21 CFR Part 117). Environmental samples tested positive for *Listeria monocytogenes* (L. mono) in seven locations, including a cutting table, floor drains, and cracked floors. A retail watermelon spear sample from May 2019 also tested positive for L. mono, with Whole Genome Sequencing (WGS) matching a 2013 environmental sample from their Houston, TX, facility and historical clinical isolates, indicating shared product, equipment, and suppliers.

The FDA determined the RTE products are adulterated under Section 402(a)(4) of the Act. Key violations include failure to identify and implement adequate preventive controls for L. mono (21 CFR 117.135(a)(1) and (c)(3)), evidenced by the positive environmental and product samples. Additionally, the firm failed to implement its preventive control for cross-contamination during washing, as an employee was observed not adhering to the required fruit holding time, and no monitoring records existed. The firm also failed to validate its preventive control for using peracetic acid to prevent cross-contamination (21 CFR 117.160), as the provided study was for food contact surfaces, not produce washing.

The