FDA 483 - Novartis Pharma Stein AG - September 21, 2018

An FDA inspection of Novartis Pharma Stein A.G., a sterile drug manufacturer in Stein, Switzerland, revealed significant issues across three observations. These included inadequate maintenance of a critical manufacturing system, lack of cleaning validation for a fill line, and failure to follow written procedures during manufacturing, specifically regarding material booking and inventory management.