FDA 483 - Catalent Pharma Solutions LLC - May 24, 2024

An FDA inspection of Catalent Pharma Solutions LLC in Morrisville, NC, from May 21-24, 2024, revealed significant issues with equipment and facility cleaning practices. Inspectors observed biological safety cabinets and laboratory floors that were not cleaned according to established procedures, leading to unidentified residues and substances. These deficiencies indicate a failure to prevent contamination that could compromise drug product quality.