FDA Inspection
OsteoSymbionics LLCOsteoSymbionics LLC – FDA Inspection, Mar 29, 2017
Record Details
This FDA Inspection record concerns OsteoSymbionics LLC, with an inspection on March 29, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 73391ff0-9b76-43bc-9e8f-95a60f8ab141
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1006041
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of OsteoSymbionics LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 3, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 3, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for OsteoSymbionics LLC
- FDA Inspection 836437 - 2013-06-25
- FDA Inspection 752758 - 2011-11-03
- FDA Inspection 696938 - 2010-11-03
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