FDA Inspection
Fresenius Medical CareFresenius Medical Care – FDA Inspection, Feb 12, 2010
Record Details
This FDA Inspection record concerns Fresenius Medical Care, with an inspection on February 12, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Fresenius Medical Care
- Inspection Date
- February 12, 2010
- Product Type
- Devices
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ID · f8328a85-e707-4c42-8fb7-60ce87b5cc8c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 642960
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.70(d)Implementing Personnel Procedures, Health, Cleanliness.
- 21 CFR 820.100(a)(3)Identifying corrective & preventive actions
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Other FDA inspections of Fresenius Medical Care
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Fresenius Medical Care
- FDA Inspection 819883 - 2013-02-07
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