FDA Inspection
Sirona Dental, IncSirona Dental, Inc – FDA Inspection, May 22, 2019
Record Details
This FDA Inspection record concerns Sirona Dental, Inc, with an inspection on May 22, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e6602e57-049e-4c06-9693-db381efaa32f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1091283
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sirona Dental, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 16, 2018 | Not classified | New York District Office | |
| December 5, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 9, 2014 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| March 19, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 4, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sirona Dental, Inc
- FDA Inspection 1102046 - 2018-11-16
- FDA Inspection 995550 - 2016-12-05
- FDA Inspection 886984 - 2014-07-09
- FDA Inspection 773064 - 2012-03-19
- FDA Inspection 603326 - 2009-08-04
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