FDA 483 - Novartis Pharma Stein AG - May 19, 2026

Novartis Pharma Stein AG, a licensed biological drug manufacturer in Stein Ag, Switzerland, was cited for significant deficiencies in its aseptic processing and quality control systems. The inspection revealed a failure to perform critical active air sampling during sterile drug product filling and a systemic breakdown in the environmental monitoring program. These issues led to the release of product without complete quality unit oversight, indicating a serious lack of control over manufacturing processes and quality assurance for sterile products.