FDA 483 - J.M. Murray Center, Inc. - September 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.