FDA 483 - Catalent Indiana, LLC

Catalent Biologics, Catalent Indiana, LLC in Bloomington, IN, a drug product manufacturer, was cited for failing to follow procedures designed to prevent microbiological contamination of sterile drug products. Inspectors observed poor aseptic techniques during setup and fill operations, including improper operator movement, lack of sanitization during interventions, and inadequate protection of equipment from contamination. These findings indicate a significant concern regarding the sterility assurance of their drug products.