FDA Inspection
Piezosurgery IncPiezosurgery Inc – FDA Inspection, Dec 13, 2011
Record Details
This FDA Inspection record concerns Piezosurgery Inc, with an inspection on December 13, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Piezosurgery Inc
- Inspection Date
- December 13, 2011
- Product Type
- Devices
View Company Profile
ID · a7732dd1-368b-4a69-9dd7-8d75a6d3a9da
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 759923
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(i)Software validation for automated processes
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 |
| March 1, 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 712899 - 2011-03-01
- FDA Inspection 656861 - 2010-04-12
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.