Compass Group USA – FDA Warning Letter, Apr 15, 2025

The FDA issued a Warning Letter to Compass Group USA regarding its Fresh & Ready Foods LLC facility in San Fernando, CA, following an inspection from March 31 to April 15, 2025. The inspection was prompted by a multi-state *Listeria monocytogenes* outbreak linked to the facility"s ready-to-eat (RTE) sandwiches, salads, wraps, and snacks, which sickened ten people and caused one death. The firm initiated a recall on May 10, 2025. FDA investigators found 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 at the facility tested positive for *Listeria monocytogenes*, matching the outbreak strain. Specifically, Fresh & Ready Foods failed to appropriately identify *Listeria monocytogenes* as a hazard requiring preventive controls, such as adequate sanitation, despite their RTE products being exposed to the environment prior to packaging. Their existing Sanitation Standard Operational Procedures and Good Manufacturing Procedures were deemed insufficient to prevent contamination. Consequently, the facility"s RTE products were considered adulterated under the Federal Food, Drug, and Cosmetic Act. While the firm submitted responses outlining corrective actions, the FDA expressed continuing concerns. Fresh & Ready Foods is required to implement robust sanitation controls and revise its hazard analysis to effectively prevent environmental pathogen contamination, ensuring compliance with federal food safety regulations.