FDA 483 - Sandoz GmbH - July 05, 2016

An FDA inspection of Sandoz GmbH in Langkampfen, Austria, revealed significant deficiencies in their quality system, laboratory controls, and aseptic processing areas. The firm failed to thoroughly investigate bioburden testing discrepancies, lacked validated procedures for component testing, and did not validate hold times for environmental monitoring samples. These issues indicate a lack of adequate controls to ensure product quality and safety.