FDA Inspection
Fresenius Medical Care Holdings, Inc.Fresenius Medical Care Holdings, Inc. – FDA Inspection, Feb 21, 2013
Record Details
This FDA Inspection record concerns Fresenius Medical Care Holdings, Inc., with an inspection on February 21, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 21, 2013
- Product Type
- Devices
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ID · dde5a34a-f3c7-4570-b312-d6d572c3f2c1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 817769
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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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 |
| January 12, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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