FDA 483 - Draegerwerk Ag & Co. Kgaa - July 04, 2022

An FDA inspection of Draegerwerk Ag & Co. KgaA in Lubeck, Germany, identified significant deficiencies in their Corrective and Preventive Action (CAPA) procedures. The firm failed to adequately review complaint records for devices like Savina/Savina 300 and Infinity ACS Workstation for CAPA consideration, despite numerous reported issues. Additionally, there was no proper corrective action taken for mislabeled product instructions for use, indicating a systemic breakdown in quality management.