FDA WARNING_LETTER - B & H Foods Inc - May 31, 2017

The FDA inspected B&H Foods' refrigerated ready-to-eat (RTE) salad manufacturing facility in Charlotte, NC, from May 9-31, 2017. Environmental swabs revealed the presence of *Listeria monocytogenes* (L. mono) in the manufacturing area, specifically on a wheel of equipment and under a packer, indicating insanitary conditions and adulterated products. Whole Genome Sequencing identified two L. mono strains, one identical to strains found in B&H Foods' Chester, SC facility since 2012, demonstrating persistent contamination.

The inspection also uncovered serious Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 110). These included: 1. **Failure to minimize microbial growth and contamination (21 CFR 110.80(b)(2))**: Observed issues included pooling water, splashing onto food contact surfaces and raw ingredients, soiled employee garments contacting food, uncleaned/unsanitized thermometers, improper storage of food contact equipment, inadequate cleaning of mixers, and improper storage and overspray of chemicals near food processing. 2. **Failure to maintain equipment to prevent contamination (21 CFR 110.80(b)(7))**: Food contact surfaces (mixers, troughs, bowls, cutting boards, salad tubs) were pitted, cracked, or gouged, making proper cleaning difficult. Conveyor belt sections were missing/broken, and chemicals were stored