FDA WARNING_LETTER - Banks Square Market Corp dba The Produce Connection - March 21, 2022

The FDA inspected a ready-to-eat (RTE) fresh-cut fruit and vegetable processing facility in Wakefield, MA, from February 8 to March 21, 2022. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR part 117).

Environmental samples collected during the inspection tested positive for *Listeria monocytogenes* (L. monocytogenes), a human pathogen, in eight of fifty-six swabs, including three from food-contact surfaces. Whole genome sequencing (WGS) identified three strains of *L. monocytogenes*, with two strains genetically identical to clinical isolates from 2019, indicating their capability to cause human illness. Non-pathogenic *Listeria* species were also found, indicating conditions suitable for *L. monocytogenes* growth. These findings led the FDA to determine that the RTE products were adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)].

The facility failed to identify and implement adequate preventive controls, specifically sanitation controls, to significantly minimize or prevent environmental pathogens like *L. monocytogenes*, as required by 21 CFR § 117.135(a)(1) and (