FDA 483 - Catalent Indiana, LLC - June 23, 2025

Catalent Indiana LLC received an FDA Form 483 following an inspection conducted from June 23 to July 14, 2025, at their Bloomington, IN sterile drug manufacturing facility. The observations primarily highlight significant deficiencies in the firm"s quality system, particularly concerning investigations into batch failures, deviations, and contamination events, indicating potential non-compliance with Current Good Manufacturing Practices.

Key issues include the inadequate investigation of atypical extrinsic particles, such as cat hair and proteinaceous mammalian hair, failing to determine root causes, assess impact on other batches, or implement effective corrective and preventive actions despite an ongoing trend. The firm"s historical reviews during investigations were deemed insufficient, with limited search scopes and a failure to consistently incorporate all relevant records, including complaints. Furthermore, Catalent Indiana failed to formally address long-standing operational issues known to staff (tribal knowledge) that led to critical defects like unseated plungers.

Additionally, the inspection revealed a lack of comprehensive investigation and mitigation strategies for recurring foreign material contamination, particularly hair linked to stoppers, and an insufficient response to microbial contamination (Staphylococcus hominis) detected in a filling head. The firm also demonstrated weaknesses in identifying and documenting all root causes and related deficiencies in various investigations, including those for pests in classified areas and microbial water monitoring excursions. Catalent Indiana LLC must comprehensively address these systemic issues by strengthening its investigation processes, implementing robust root cause analyses, and ensuring effective corrective and preventive actions are developed and implemented to achieve and maintain regulatory compliance.