FDA 483 - Catalent Indiana, LLC - October 18, 2019

Catalent Indiana, LLC, a contract drug manufacturer in Bloomington, IN, was cited for five observations related to significant deficiencies in their manufacturing and quality control processes. These issues include inadequate storage conditions, failure to follow written procedures for visual inspection, insufficient controls to prevent microbiological contamination, and poor equipment maintenance practices. The findings indicate a lack of adherence to cGMP requirements, potentially impacting drug product quality and safety.