FDA EIR - Catalent Indiana, LLC - September 02, 2020

An FDA inspection of Catalent Indiana, LLC, a drug substance and drug product manufacturing facility in Bloomington, IN, was conducted from August 27 to September 2, 2020. This risk-based inspection supported a drug product review and followed regulatory frameworks including CPGM 7356.002M, CPGM 7346.832, and ICH Q7. The assessment covered Quality, Facilities/Equipment, Production, Materials, Packaging and Labeling, and Laboratory Control Systems. The main violation noted was a single FDA-483 observation indicating that procedures designed to prevent microbiological contamination in sterile drug products were either not written or not followed. Three additional verbal concerns were also discussed with management. While a previous inspection in 2019 had resulted in five FDA-483 observations, the firm’s responses to those were found adequate. Catalent Indiana, LLC committed to responding to the latest FDA-483 observation within 15 business days. Many of the firm's corrective actions from the prior inspection were already in progress during this audit. The inspection concluded with a "Voluntary Action Indicated" decision.