FDA Inspection
Piezosurgery IncPiezosurgery Inc – FDA Inspection, Jun 28, 2017
Record Details
This FDA Inspection record concerns Piezosurgery Inc, with an inspection on June 28, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ad870d6a-6388-42d4-bce1-de810746e69c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017087
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Piezosurgery Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| April 12, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Piezosurgery Inc
- FDA Inspection 860088 - 2013-12-16
- FDA Inspection 759923 - 2011-12-13
- FDA Inspection 712899 - 2011-03-01
- FDA Inspection 656861 - 2010-04-12
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