FDA WARNING_LETTER - Old Europe Cheese, Inc. - October 06, 2022

On March 17, 2023, the FDA issued a Warning Letter to Old Europe Cheese, Inc. following an inspection from September 13 to October 6, 2022, conducted jointly with the Michigan Department of Agriculture and Rural Development (MDARD). The inspection was prompted by a multistate *Listeria monocytogenes* (L. mono) outbreak linked to the firm's ready-to-eat (RTE) soft cheese products, which resulted in six illnesses across six states. One environmental swab from the facility matched the outbreak strain via Whole Genome Sequencing (WGS).

The FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (21 CFR Part 117), deeming the RTE Brie and Camembert Soft Cheese products adulterated. Violations included: 1. **Inadequate Hazard Analysis (21 CFR 117.130(a)(1)):** Failure to identify "Post-Pasteurization Contamination" (e.g., *L. monocytogenes*) and "Environmental Contamination (Listeria)" as hazards requiring preventive controls, despite a positive *L. monocytogenes* swab from a post-pasteurization area matching the outbreak strain. Also, failure to identify bacterial pathogens as a hazard requiring process control for "Cooler Storage" and a supply-chain program for ingredients added post-paste