# FDA 483 - Fresenius Medical Care Holdings, Inc. - October 16, 2024

Source: https://www.keypedia.com/records/483/fresenius-medical-care-holdings-inc/e022677b-2fe9-411b-8dfb-8672a3c711e6

> FDA 483 for Fresenius Medical Care Holdings, Inc. on October 16, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Medical Care Holdings, Inc.
- Inspection Date: 2024-10-16
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Fresenius Medical Care Holdings, Inc. in Waltham, MA, revealed significant deficiencies in their quality system, particularly concerning corrective and preventive actions, design change validation, risk analysis, and supplier management. The firm failed to adequately address repeat observations, properly assess CAPA impacts, validate critical device design changes, or appropriately analyze serious complaints, including one associated with a patient death. These findings indicate a high level of non-compliance with regulatory requirements for medical device manufacturing.

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## Related Officers

- [Sunita Pandey](https://www.keypedia.com/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

Company: https://www.keypedia.com/companies/fresenius-medical-care-holdings-inc/71c8f1ab-77b5-4c59-ad13-3f0de5b7a6f3

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144