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

Source: https://www.keypedia.com/records/483/draegerwerk-ag-co-kgaa/f8979cbb-3f63-41ad-b37e-ccbf9f099497

> FDA 483 for Draegerwerk Ag & Co. Kgaa on July 04, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Draegerwerk Ag & Co. Kgaa
- Inspection Date: 2022-07-04
- Product Type: device
- Office Name: International Compliance Team
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.keypedia.com/companies/draegerwerk-ag-co-kgaa/88ce7a7b-9a41-4d74-99a0-d042ac6d3c18

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321