J.M. Murray Center, Inc. – FDA 483, Sep 19, 2025

J.M. Murray Center, Inc. in Cortland, NY, an OTC manufacturer, was cited for significant deficiencies in its manufacturing controls. The inspection revealed inadequate equipment cleaning procedures and a lack of cleaning validation, absence of written process validation protocols for drug products, and a failure to establish programs for evaluating drug product quality standards and stability testing. These issues indicate a systemic lack of adherence to Good Manufacturing Practices.