Catalent Indiana, LLC – FDA 483, Sep 1, 2022

The FDA Form 483 document outlines multiple observations from an inspection of a pharmaceutical manufacturing facility.

**Observation 1** details failures in thoroughly investigating discrepancies and out-of-specification (OOS) results. This includes releasing vials exceeding visible particle specifications, an inadequate investigation into an atypical particle found in the motor above the aseptic filling line, and insufficient investigation of batches exceeding internal control limits. A retest of particulate matter for a product did not follow the required OOS procedure, and the justification for changing a critical reject definition for bent components was not provided, with no re-evaluation of rejected items or investigation into the root cause.

**Observation 2** highlights inadequate investigation and follow-up for drug complaints. Specifically, 179 complaints for particles were received, but the particles were not analyzed, and retain samples were not inspected. Additionally, 52 supplier complaints for stopper-related issues were noted, with 17 related to a specific stopper item, and investigations largely relied on supplier conclusions without adequate firm investigation into repeat defects or extension of investigations to other batches.

**Observation 3** indicates that control processes are not established to monitor output and validate manufacturing processes. Internal defect control limits were not set for the measurement system inspection process, and AQL samples were not representative of the entire batch, with inadequate documentation for AQL sampling and segregation of non-conforming product.

**Observation 5** addresses equipment design issues. The firm did not demonstrate that