FDA 483 - Sandoz GmbH - January 12, 2023

An FDA inspection of Sandoz GmbH in Langkampfen, Austria, a pharmaceutical manufacturer, revealed two significant deficiencies. The firm failed to adequately establish procedures for verifying the effectiveness of corrective and preventive actions (CAPA) and for properly investigating product complaints, specifically concerning malfunctions of Hyrimoz. These issues indicate a moderate level of non-compliance with quality system requirements.