FDA WARNING_LETTER - U.F.S. Industries, Inc. d.b.a. Sally Sherman Foods - March 07, 2019

The FDA inspected U.F.S. Industries, Inc. d.b.a. Sally Sherman Foods, a Ready-to-Eat (RTE) salads and prepared foods manufacturer, from February 11 to March 7, 2019. The inspection revealed serious violations of the CGMP & PC rule (21 CFR Part 117) and the Seafood HACCP regulation (21 CFR Part 123). Environmental samples tested positive for *Listeria monocytogenes* (L. monocytogenes), including on non-food-contact surfaces near food processing, indicating insanitary conditions and adulterated RTE products.

Key violations include: - **Hazard Analysis and Risk-Based Preventive Controls:** Failure to identify and implement preventive controls for environmental pathogens like *L. monocytogenes*, evidenced by positive environmental swabs, including from equipment obtained from another facility that shared the same *L. monocytogenes* strain. Inadequate written procedures for product testing and environmental monitoring. Inadequate allergen control procedures, specifically not identifying fish as an allergen and observing cross-contact during production. - **Supply-Chain Program:** Failure to conduct and document appropriate supplier verification activities for ingredients like black pepper, which requires supply chain controls. - **Current Good Manufacturing Practice:** Cold storage units lacked accurate temperature devices, with sensors out-of-service for an extended period. The facility's construction had disrepair (pits, grooves, cracks in floors