FDA 483 - J.M. Murray Center, Inc. - April 30, 2021

J.M. Murray Center, Inc., a drug repacker and relabeler in Cortland, NY, was cited for significant deficiencies across multiple areas during an FDA inspection. Observations included inadequate cleaning validation, lack of written production and process control procedures, a quality control unit lacking authority for batch record review, and deficient equipment calibration practices. These issues indicate a systemic lack of control over critical manufacturing and quality processes.