# FDA 483 - Fresenius Medical Care Holdings, Inc. - June 03, 2026

Source: https://www.keypedia.com/records/483/fresenius-medical-care-holdings-inc/b05c1eca-999c-477d-be0b-4577f7e1de3b

> FDA 483 for Fresenius Medical Care Holdings, Inc. on June 03, 2026. 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: 2026-06-03
- Product Type: device
- Office Name: New England District Office
- Summary: Fresenius Medical Care Renal Therapies Group, LLC in Waltham, MA, received a Form 483 with six observations detailing significant deficiencies in their quality system for hemodialysis machines and related products. The inspection revealed inadequate risk management, design verification, and design validation, leading to potential patient harm and death. Furthermore, the firm failed to properly utilize feedback for risk management, implement effective corrective actions, and establish adequate supplier controls.

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## Related Officers

- [Sunita Pandey](https://www.keypedia.com/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)
- [Thomas Siebertz](https://www.keypedia.com/people/thomas-siebertz/a2547520-c652-4303-822c-e32648dc9b01)

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