FDA 483 - Novartis Manufacturing LLC - March 04, 2025

An FDA inspection of Novartis Manufacturing LLC in Indianapolis, IN, a sterile drug manufacturer, identified three significant observations. The firm was cited for failing to adequately qualify component suppliers by verifying their analyses, not including in-process control results in batch production records, and for its quality control unit not consistently following complaint handling procedures, resulting in numerous unresolved complaints. These issues indicate deficiencies in quality control and record-keeping practices.