FDA 483 - Novartis Pharma Stein AG - December 06, 2022

Novartis Pharma Stein AG, a drug product manufacturer in Stein Ag, Switzerland, was cited with five observations during an FDA inspection from November 28 to December 6, 2022. The inspection revealed significant deficiencies in aseptic processing procedures, equipment design, process validation, adherence to written procedures, and facility maintenance. These issues indicate a lack of adequate controls to ensure the sterility, quality, and integrity of drug products.