FDA 483 - Catalent Indiana, LLC - May 12, 2023

This FDA Form 483 details observations from an inspection, citing deficiencies in production and process controls, equipment maintenance, and quality system documentation.

**Violations and Observations:**

* **Aseptic Technique Non-Adherence:** * Failure to sanitize gloved hands during Flexible Fill Line stopper bowl setup. * Incorrect transfer of stopper bowl from Grade C to Grade A space (bag not removed in Grade C). * Complete removal of stopper bowl covering in Grade A, with a fill technician's exposed face over the uncovered bowl. * Use of an unsterilized tool (forceps) for stopper jam dislodgement, expelling air onto a sanitized surface, violating aseptic intervention procedures. * Failure to visually inspect gloved hands for multiple interventions on the Vial Filling Line. * **Equipment Sterilization and Integrity:** * Sterilization of equipment within an isolator for docking to the Flexible Fill Line, where the isolator's integrity is not tested post-manufacture. * Risk assessment (RA-21-05-001) fails to evaluate isolator integrity testing. * Integrity of the (b)(4) for the Flexible Fill Line (b)(4) (sterile) (b)(4), conducted on a (b)(4) basis, is not considered in batch release. Corrective action for this deficiency is