FDA Inspection
Ossur AmericasOssur Americas – FDA Inspection, Aug 21, 2014
Record Details
This FDA Inspection record concerns Ossur Americas, with an inspection on August 21, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ossur Americas
- Inspection Date
- August 21, 2014
- Product Type
- Devices
View Company Profile
ID · 999076b2-71f9-46a7-aab3-fbc69706acb7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 897335
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.72(a)Equipment control activity documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ossur Americas
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 27, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 19, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 7, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 8, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ossur Americas
- FDA Inspection 1063083 - 2018-07-17
- FDA Inspection 986687 - 2016-09-27
- FDA Inspection 808387 - 2012-11-19
- FDA Inspection 679074 - 2010-09-07
- FDA Inspection 552662 - 2008-12-08
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