FDA Inspection
Piezosurgery IncPiezosurgery Inc – FDA Inspection, Mar 1, 2011
Record Details
This FDA Inspection record concerns Piezosurgery Inc, with an inspection on March 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Piezosurgery Inc
- Inspection Date
- March 1, 2011
- Product Type
- Devices
View Company Profile
ID · 4eaa0abd-f7ae-4049-9d20-8cd341871c05
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 712899
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.25(b)Training records
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Piezosurgery Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 16, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 13, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 12, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Piezosurgery Inc
- FDA Inspection 1017087 - 2017-06-28
- FDA Inspection 860088 - 2013-12-16
- FDA Inspection 759923 - 2011-12-13
- FDA Inspection 656861 - 2010-04-12
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