FDA 483 - Novartis Pharma AG - August 30, 2022

Novartis Pharma AG, a drug substance manufacturer in Basel, Switzerland, received three observations during an FDA inspection. The inspection identified deficiencies related to inadequate controls for computerized systems, insufficient qualification of equipment used for stability sample storage, and a lack of adequate reserve samples for quality control analysis. These findings highlight concerns with data integrity, equipment validation, and quality control procedures at the facility.