FDA 483 - Catalent Indiana, LLC - September 01, 2022

From August 1 to September 1, 2022, the FDA inspected Catalent Indiana, LLC, a sterile human drug and biologic product manufacturer in Bloomington, IN. The inspection identified eleven observations.

Observation 1 notes the firm failed to thoroughly investigate unexplained discrepancies or failures of batches to meet specifications, specifically regarding visible particles in released batches between August 11, 2021, and an unspecified date, which exceeded the supplemental visible particles specification.

Observation 2 states written records of drug complaint investigations lack findings and follow-up, citing 179 complaints received for various particulates.

Observation 3 indicates control procedures are not established to monitor output and validate manufacturing processes causing variability, specifically the lack of internal defect control limits for the (b)(4) inspection process, noted in batches from 2019.

Observation 5 details that equipment used in manufacturing is not of appropriate design for its intended use. This includes the firm not demonstrating the (b)(4) is better than or equivalent to (b)(4) inspection, not considering individual defect vial performance during acceptance criteria establishment for (b)(4) Performance Qualification, and not evaluating instances where defects were missed by the (b)(4) due to averaging. Additionally, the firm did not evaluate extrinsic particulate detectability.

Observation 6 highlights that procedures to prevent microbiological contamination of sterile drug products are not established, written, or followed, citing deficiencies in airflow studies where acceptance criteria