FDA Inspection
Fresenius USA, Inc.Fresenius USA, Inc. – FDA Inspection, Dec 7, 2011
Record Details
This FDA Inspection record concerns Fresenius USA, Inc., with an inspection on December 7, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Fresenius USA, Inc.
- Inspection Date
- December 7, 2011
- Product Type
- Devices
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ID · dc15f84f-0bea-4517-828f-21ce8400969e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 755564
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.100(a)Lack of or inadequate procedures
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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 |
| February 22, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 822364 - 2013-02-22
- FDA Inspection 748172 - 2011-10-24
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