FDA 483 - Novartis Pharmaceuticals Corporation - August 08, 2024

Novartis Pharmaceuticals Corporation in Morris Plains, NJ, was cited for significant deficiencies in its manufacturing processes for sterile drug products, particularly Kymriah®. The inspection revealed issues with microbiological contamination prevention, inadequate laboratory controls for foreign particulates, and failures in quality control unit procedures regarding change control and batch record review. Additionally, the firm lacked appropriate computer system controls, indicating a broad range of compliance concerns.