FDA 483 - Catalent Indiana, LLC - November 15, 2023

This FDA Form 483 was issued to Catalent Indiana, LLC, a manufacturer located at 1300 S Patterson Dr, Bloomington, IN 47403-4828, following an inspection from October 31 to November 15, 2023. The report was issued to Scott G. Gunther, Vice President, Quality and Regulatory Affairs.

The inspection revealed six observations:

1. **Quality Control Unit Deficiencies:** The Quality Unit did not fully follow its responsibilities and procedures, failing to ensure drug products meet GMPs and specifications. This included inadequate investigation of errors, insufficient validation/revalidation, unqualified personnel for visual inspection, and poor equipment maintenance. 2. **Inadequate Discrepancy Review:** The firm failed to thoroughly review unexplained discrepancies and batch failures. Approximately 194 deviations related to (b)(4) failures occurred between October 2021 and October 2023, with 171 lacking a definitive root cause. No commercial drug or biological drug product lots were rejected due to these failures, despite approximately (b)(4) associated batches. 3. **Sterile Process Validation Issues:** Procedures to prevent microbiological contamination of sterile drug products lacked adequate aseptic process validation. Specifically, designs of multiple vial and syringe line systems did not allow all (b)(4) to be (b)(4) with (b)(4). 4