Novartis d.o.o. – FDA 483, Jul 21, 2023

An FDA inspection of Novartis Pharmaceutical Manufacturing LLC in Mengeš, Slovenia, a drug substance manufacturer, revealed significant deficiencies in quality unit oversight, manufacturing process controls, and environmental monitoring. Issues included errors in validation studies, conflicting sample storage information, inadequate batch record verification, and unsuitable environmental monitoring limits. The findings indicate a lack of robust quality systems and process control, potentially impacting product quality and safety.