FDA 483 - Catalent CTS, LLC - October 23, 2018

Catalent CTS, LLC in Kansas City, MO, a drug manufacturer, was inspected by the FDA from October 15-23, 2018. The inspection revealed significant deficiencies in quality control, data integrity, and facility design, particularly concerning the manufacturing process and record-keeping for Selinexor 20mg tablets. Issues included inadequate investigation of discrepancies, insufficient computer system controls, and poor material flow design leading to potential contamination risks.