FDA 483 - Catalent CTS, LLC - November 10, 2014

An FDA inspection of Catalent CTS (Kansas City), LLC identified significant deficiencies in the manufacturing and control of Lomitapide capsules. The firm failed to adequately validate analytical methods, establish proper control procedures for wet granulation, and maintain complete master batch records. Additionally, the company did not thoroughly investigate out-of-trend results, indicating a lack of robust quality oversight.