FDA 483 - Catalent Indiana, LLC - September 02, 2020

An FDA inspection of Catalent Biologics, Catalent Indiana, LLC, a drug product manufacturer located in Bloomington, IN, was conducted from August 27 to September 2, 2020. The inspection identified significant observations regarding the company's adherence to aseptic processing standards for sterile drug products. The primary violation noted was the failure to consistently follow established procedures designed to prevent microbiological contamination. Inspectors observed instances where good aseptic techniques were not maintained during the setup and fill operations for a sterile drug product. Specific issues included operators not adhering to controlled movement protocols as outlined in standard operating procedures (SOPs). Furthermore, operators performed interventions in the aseptic area without properly sanitizing their gloves, a direct contravention of the company's own guidelines. There were also observations of improper handling and storage of equipment, such as a scoop, which came into contact with soiled or non-sterile surfaces, potentially compromising sterility. These findings highlight a need for Catalent Biologics to review and reinforce its aseptic processing controls to ensure compliance with cGMP regulations and prevent potential contamination of sterile drug products. The company is expected to implement prompt corrective actions to address these critical deviations.