Morton Drug Company dba Morton LTC – FDA 483, Dec 22, 2015

An FDA inspection of Morton Drug Company dba Morton LTC, a sterile drug producer, conducted from December 15-22, 2015, revealed significant deficiencies in its manufacturing processes, primarily under Current Good Manufacturing Practices (CGMP). Key violations centered on inadequate aseptic processing controls. Specifically, the "clean room" and ante room were not classified, pressure differentials were unmonitored, and ISO 5 components were not sterile. Environmental monitoring procedures were lacking, with no active air, personnel, or surface monitoring during daily sterile drug preparation, and pressure differential results were undocumented. Further issues included deficient laboratory controls, as the firm lacked a procedure for 100% visual inspection of finished sterile products, a lapse observed with Cefazolin and Cubicin batches. Beyond-use dates were improperly assigned; for example, Clindamycin was given a 9-day room temperature BUD without stability data, instead of the correct 30 hours, leading to distributed non-compliant products. Protective apparel was insufficient, with technicians' arms, faces, and clothing exposed during aseptic processing. Sterilization process validation was also inadequate; media fill studies lacked environmental monitoring, and a re-qualification study with an out-of-range incubation temperature was accepted without investigation. Additionally, cleaning agents and disinfectants used in the sterile area were not sterile. Morton Drug Company must implement comprehensive corrective actions to address these critical findings and ensure compliance with regulatory standards for sterile drug manufacturing.