FDA WARNING_LETTER - Catalent Indiana, LLC - July 14, 2025

The FDA issued a Warning Letter to Catalent Indiana, LLC, following an inspection from June 23 to July 14, 2025, for significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The primary issue highlighted was the company"s failure to thoroughly investigate unexplained discrepancies and batch failures, rendering drug products adulterated. Specifically, Catalent Indiana, LLC experienced over 20 deviations since August 2023 involving extrinsic "mammalian hair" contamination in sterile drug product vials. Investigations into these incidents were inadequate, lacking sufficient data, trend analysis, and effective corrective and preventive actions (CAPAs) with suppliers. Despite finding contamination, the quality unit released affected batches, leading to subsequent customer complaints and rejections. Additionally, the company failed to initiate timely and thorough investigations for more than five terminated media fill batches, without providing root cause analysis or corrective actions for these events. The FDA requires Catalent Indiana, LLC to submit a comprehensive, independent assessment of its investigation and complaint handling systems, including a detailed remediation plan for improving investigation competencies, root cause analysis, CAPA effectiveness, and quality assurance oversight. An independent review of rejected vials for extrinsic particles and an assessment of the CAPA program are also mandated.