Banks Square Market Corp. dba The Produce Connection Warning Letter Details

Summary

Banks Square Market Corp. dba The Produce Connection, a ready-to-eat fresh-cut fruit and vegetable processor in Wakefield, Massachusetts, violated Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls regulations under 21 CFR Part 117. During an FDA inspection from February through March 2022, investigators detected Listeria monocytogenes, a human pathogen, in environmental swabs collected from multiple areas of the processing facility, rendering the facility's RTE products adulterated under the Federal Food, Drug, and Cosmetic Act due to preparation, packing, or storage under insanitary conditions. The violations included failure to implement required preventive controls and sanitation procedures that could have prevented contamination of food products.