# FDA 483 - Fresenius Medical Care Holdings, Inc. - October 07, 2022

Source: https://www.keypedia.com/records/483/fresenius-medical-care-holdings-inc/b77730cc-2305-4d02-83f6-292a2c6f8eff

> FDA 483 for Fresenius Medical Care Holdings, Inc. on October 07, 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: 2022-10-07
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Fresenius Medical Care Holdings, Inc. in Ogden, UT, received a Form 483 with three observations during an FDA inspection. The firm's corrective and preventive action procedures were found inadequate, specifically lacking verification of effectiveness for changes made to address product issues. Additionally, a critical manufacturing process for bloodlines was not adequately validated, and complaint handling procedures failed to ensure proper evaluation for Medical Device Reporting requirements, even in cases involving patient death.

## Related Officers

- [Christopher M. Cox](https://www.keypedia.com/people/christopher-m-cox/15ce681f-a87d-4f98-a1ee-2ea574ce53c8)
- [Michael J. Kayser](https://www.keypedia.com/people/michael-j-kayser/8b837046-cdf8-42f3-b507-409aa5001826)

Company: https://www.keypedia.com/companies/fresenius-medical-care-holdings-inc/fbc44b42-645d-4ab0-a8d7-960266c71e74

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