FDA 483 - Catalent Pharma Solutions LLC - March 04, 2019

An FDA inspection of Catalent Pharma Solutions LLC in Morrisville, NC, a contract manufacturer and testing lab, revealed four significant observations. The firm was cited for inadequate procedures to prevent microbial contamination, deficiencies in equipment design and qualification, failures in investigating unexplained discrepancies, and an insufficient preventative maintenance program. These findings indicate moderate issues with the firm's manufacturing controls and quality systems.