# FDA 483 - Fresenius Medical Care Holdings, Inc. - October 05, 2022

Source: https://www.keypedia.com/records/483/fresenius-medical-care-holdings-inc/4cf73d12-d2bb-41f0-b209-0f3856925c69

> FDA 483 for Fresenius Medical Care Holdings, Inc. on October 05, 2022. 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: 2022-10-05
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Fresenius Medical Care Holdings, Inc. in Waltham, MA, revealed significant deficiencies in the firm's quality system. Observations included inadequate corrective and preventive action procedures, unvalidated manufacturing processes, and failures in complaint handling. These issues indicate a lack of robust controls for ensuring device quality and patient safety, particularly concerning medical device reporting evaluations.

## Related Officers

- [Yogesh K. Bombay, Investigator/CS](https://www.keypedia.com/people/yogesh-k-bombay-investigatorcs/29383d70-bd10-41dc-adf3-1ef68284b251)
- [Michael J. Babola, Investigator/CS](https://www.keypedia.com/people/michael-j-babola-investigatorcs/f5ceb4cc-4c44-46b9-81f4-8a3b8c443414)

Company: https://www.keypedia.com/companies/fresenius-medical-care-holdings-inc/e3a514fd-5526-46ad-ad71-e18b86cf966c

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248