Catalent Indiana LLC — FDA 483 Findings

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions, Specifically, Environmental monitoring is not always performed in response to interventions located and / or impacting critical surfaces.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization processes.

Master production and control records lack complete manufacturing and control instructions.

Equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use.

Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.

The responsibilities and procedures applicable to the quality unit are not in writing and fully followed.

The number of containers and amount of material taken from each container is not based upon appropriate criteria.

Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in- process material and the drug product.