Draegerwerk Ag & Co. Kgaa – FDA 483, Jul 4, 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.
ID · f8979cbb-3f63-41ad-b37e-ccbf9f099497
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