FDA 483 - Catalent Pharma Solutions, LLC - January 11, 2023

An FDA inspection of Catalent Pharma Solutions LLC in Winchester, KY, revealed significant deficiencies in laboratory record review processes. The firm failed to ensure a second person reviewed original records for accuracy, impacting both microbial plate counts and raw material identity testing data. These lapses indicate a serious concern regarding data integrity and quality control within the manufacturing process.