FDA 483 - Catalent Pharma Solutions, LLC - April 22, 2025

An unnamed pharmaceutical manufacturing firm received an FDA Form 483 following an inspection conducted from April 14 to April 22, 2025. The inspection, led by Geoffrey K. Kilili, identified significant deviations from regulatory requirements under Christopher M. Rosenbaum, General Manager. The primary concerns revolved around two key areas. Firstly, the firm failed to adequately review unexplained discrepancies and batch specification failures. Specifically, there was an absence of a robust environmental monitoring program for HEPA-filtered process air, and no established microbial limits for such air. An investigation into mold contamination in drug product granulation in June 2021 revealed Fusarium sporotrichioides in process air. Despite this, the firm failed to expand the investigation to other systems or implement periodic microbial monitoring for process air, raising concerns about potential ongoing contamination. Secondly, the firm did not adhere to its written procedures for equipment cleaning and maintenance. An instance on March 18, 2025, showed a fluid bed processor identified as clean despite containing a pool of stale, black/grey liquid at the bottom of its air inlet. This directly contradicted the firm's own procedures requiring visual inspection and verification of dryness and absence of residue. These observations indicate a need for the firm to implement comprehensive corrective actions to ensure compliance with good manufacturing practices and prevent potential product contamination and quality issues. The FDA expects a thorough response addressing each observation.