FDA 483 - Novartis Singapore Pharmaceutical Manufacturing Pte.

An FDA inspection of Novartis Singapore Pharmaceutical Manufacturing Pte Ltd. revealed significant deficiencies in quality control and manufacturing processes. The firm failed to adequately investigate root causes for deviations, leading to recurrent bioburden and endotoxin excursions, and approved analytical method transfers without scientific justification. Additionally, procedures for OOS investigations, critical material management, and adherence to production controls were found to be inadequate.