FDA Inspection
Fresenius USA, Inc.Fresenius USA, Inc. – FDA Inspection, Feb 22, 2013
Record Details
This FDA Inspection record concerns Fresenius USA, Inc., with an inspection on February 22, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Fresenius USA, Inc.
- Inspection Date
- February 22, 2013
- Product Type
- Devices
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ID · fc5dcf43-7d33-4536-b14d-94fc71aa2ce4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 822364
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fresenius USA, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| August 27, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 30, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 14, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 7, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 24, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Fresenius USA, Inc.
- FDA Inspection 940274 - 2015-08-27
- FDA Inspection 864135 - 2014-01-30
- FDA Inspection 822918 - 2013-03-14
- FDA Inspection 755564 - 2011-12-07
- FDA Inspection 748172 - 2011-10-24
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