FDA Inspection
Piezosurgery IncPiezosurgery Inc – FDA Inspection, Apr 12, 2010
Record Details
This FDA Inspection record concerns Piezosurgery Inc, with an inspection on April 12, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Piezosurgery Inc
- Inspection Date
- April 12, 2010
- Product Type
- Devices
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ID · 256c4b93-2344-4db5-b22c-e871dc187ee0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 656861
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(a)Complete files maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 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 |
| March 1, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 712899 - 2011-03-01
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