FDA 483 - Novartis Pharma Stein AG - December 04, 2018

An FDA inspection of Novartis Pharma Stein AG, a biological drug manufacturer in Stein, Switzerland, revealed significant deficiencies. Observations included inadequate environmental monitoring during aseptic processing, poor facility maintenance with a leaking cooling unit affecting drug product storage, and pre-dating of production and process control documentation. These issues indicate a lack of control over critical manufacturing processes and facility conditions.