FDA 483 - Novartis Manufacturing LLC - October 23, 2023

An FDA inspection of Novartis Manufacturing, LLC. in Indianapolis, IN, revealed two significant observations related to the firm's quality control and laboratory operations. The inspection found deficiencies in the completeness of laboratory records for reference standard characterization and inadequate procedures for the acceptance and testing of incoming reference standards. These issues indicate a lack of robust control over critical laboratory materials used in drug product testing.