FDA Inspection
Fresenius Medical Care Holdings, Inc.Fresenius Medical Care Holdings, Inc. – FDA Inspection, Jan 12, 2018
Record Details
This FDA Inspection record concerns Fresenius Medical Care Holdings, Inc., with an inspection on January 12, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · dac3dd49-a24b-4b19-8c5d-755b7c3cf548
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037657
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fresenius Medical Care Holdings, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| June 3, 2026 | Not classified | New England District Office | Compliance: Devices |
| October 16, 2024 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 2, 2023 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 2, 2019 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| October 19, 2017 | Not classified | New England District Office |
Other documents for Fresenius Medical Care Holdings, Inc.
- FDA Inspection 1322950 - 2026-06-03
- FDA Inspection 1237243 - 2024-10-16
- FDA Inspection 1214802 - 2023-08-02
- FDA Inspection 1098363 - 2019-08-02
- FDA Inspection 1051942 - 2017-10-19
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