FDA Inspection
Tornier, IncTornier, Inc – FDA Inspection, May 14, 2009
Record Details
This FDA Inspection record concerns Tornier, Inc, with an inspection on May 14, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tornier, Inc
- Inspection Date
- May 14, 2009
- Product Type
- Devices
View Company Profile
ID · fb28416b-4e7f-4472-b66f-fb3ab1622e93
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 586544
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40(b)Change records, content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Tornier, Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 26, 2014 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| January 31, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 3, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 11, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Tornier, Inc
- FDA Inspection 938240 - 2015-07-15
- FDA Inspection 872141 - 2014-03-26
- FDA Inspection 817044 - 2013-01-31
- FDA Inspection 754158 - 2011-11-03
- FDA Inspection 633844 - 2009-12-11
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