FDA 483 - Novartis Pharmaceuticals Corporation - August 21, 2019

During an inspection from August 13-21, 2019, Novartis Pharmaceuticals Corp in Morris Plains, NJ, was cited for significant deficiencies in manufacturing process controls for its Kymriah (tisagenlecleucel) product. Issues included inadequate validation of manufacturing processes leading to cell viability failures, insufficient procedures to prevent microbiological contamination in sterile drug production, and ineffective investigation and management of out-of-specification results and corrective actions. These observations indicate a lack of robust quality systems impacting product stability and sterility assurance.