FDA Inspection
Sirona Dental, IncSirona Dental, Inc – FDA Inspection, Aug 4, 2009
Record Details
This FDA Inspection record concerns Sirona Dental, Inc, with an inspection on August 4, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sirona Dental, Inc
- Inspection Date
- August 4, 2009
- Product Type
- Devices
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ID · ded0e5d6-3414-4894-9585-db3e97f94480
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 603326
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
12- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review procedures - personnel
- 21 CFR 820.180Availability
- 21 CFR 820.180Legibility
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.184(f)Device identification, control numbers
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.100(a)Lack of or inadequate procedures
Showing 10 of 12 citations.
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Other FDA inspections of Sirona Dental, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2019 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| 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 |
Other documents for Sirona Dental, Inc
- FDA Inspection 1091283 - 2019-05-22
- FDA Inspection 1102046 - 2018-11-16
- FDA Inspection 995550 - 2016-12-05
- FDA Inspection 886984 - 2014-07-09
- FDA Inspection 773064 - 2012-03-19
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