FDA Inspection
Accuray IncorporatedAccuray Incorporated – FDA Inspection, May 10, 2011
Record Details
This FDA Inspection record concerns Accuray Incorporated, with an inspection on May 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Accuray Incorporated
- Inspection Date
- May 10, 2011
- Product Type
- Devices
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ID · e8724302-c35c-4fb7-8a5a-e66d13245d67
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 722785
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
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Other FDA inspections of Accuray Incorporated
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2016 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| June 12, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 3, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Accuray Incorporated
- FDA Inspection 979676 - 2016-08-09
- FDA Inspection 930148 - 2015-06-12
- FDA Inspection 789262 - 2012-07-03
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