FDA 483 - Diversified CPC International - June 16, 2023

An FDA inspection of Diversified CPC International in Channahon, IL, revealed significant deficiencies in the control of manufacturing, testing, and release of aerosol propellants used in drug products. Key issues included a lack of quality unit oversight, inadequate assessment of propellant contamination, and widespread problems with data integrity and computerized system controls. The firm also failed to establish proper method validation and system suitability for analytical testing, indicating a serious lack of adherence to current Good Manufacturing Practices.