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Cooperstown Cheese Company, LLC, a ready-to-eat raw milk cheese manufacturer in New York, failed to comply with Current Good Manufacturing Practice and Hazard Analysis requirements under 21 CFR Part 117 during an FDA inspection from June-July 2023. FDA environmental sampling detected Listeria monocytogenes, a human pathogen, in multiple areas of the production facility, rendering the company's RTE cheese products adulterated under federal law due to preparation, packing, and storage under insanitary conditions. The facility's violations created a risk that products may have become contaminated with filth or rendered injurious to health.