Middlefield Original Cheese Cooperative – FDA Warning Letter, Sep 8, 2025

Following an inspection from August 12, 2025, through September 8, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to Middlefield Original Cheese Cooperative in Middlefield, Ohio. This action was prompted by a previous voluntary recall after the company discovered Listeria monocytogenes in its cheese products. The inspection revealed significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulations (21 CFR Part 117). Key issues identified include the persistent presence of Listeria within the production environment, failure to implement adequate preventive controls for pathogens, and a lack of consistent monitoring for sanitizer concentrations. Investigators also found that the facility failed to maintain proper record-keeping, as numerous sanitation and temperature logs lacked required signatures and dates. Furthermore, the company’s recall plan was deemed insufficient because it did not define clear communication procedures or assign staff responsibilities. Physical inspections also uncovered pest infestations, including live cockroaches and evidence of rodents in close proximity to production areas. The FDA determined the firm"s previous corrective action responses were inadequate because they lacked root-cause investigations and documented evidence of completion. Middlefield Original Cheese Cooperative must respond within 15 working days with a detailed plan and evidence of corrective measures to address these safety failures. Failure to comply may lead to further legal action, such as product seizures or the suspension of the facility’s registration.