FDA 483 - Novartis Pharmaceuticals Corporation

An inspection of Novartis Pharmaceuticals Corporation's gene therapy product manufacturing facility in Morris Plains, NJ, revealed significant deficiencies. The firm's process validation for CTL-019 manufacturing was incomplete, with issues noted in the process performance qualification study and un-evaluated changes to the commercial process. Additionally, the facility failed to initiate or investigate deviations for numerous microbial monitoring action level excursions.