FDA Inspection
Osseon LLCOsseon LLC – FDA Inspection, Mar 22, 2013
Record Details
This FDA Inspection record concerns Osseon LLC, with an inspection on March 22, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Osseon LLC
- Inspection Date
- March 22, 2013
- Product Type
- Devices
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ID · 863903e9-e4e7-4c79-815a-ccebb7b1e90d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 823242
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.30(g)Design validation - user needs and intended uses
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Other FDA inspections of Osseon LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 27, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 15, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Osseon LLC
- FDA Inspection 961500 - 2016-02-05
- FDA Inspection 788278 - 2012-06-27
- FDA Inspection 619894 - 2009-09-15
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