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

J.M. Murray Center, Inc. in Cortland, NY, a drug repacker and relabeler, was inspected and cited for significant deficiencies across four observations. These issues include inadequate equipment cleaning validation, lack of written production and process control procedures, a quality control unit that lacks authority to review production records, and improper calibration of equipment. The findings indicate a systemic lack of adherence to good manufacturing practices.