FDA Inspection
Ivoclar Vivadent, Inc.Ivoclar Vivadent, Inc. – FDA Inspection, Jan 11, 2018
Record Details
This FDA Inspection record concerns Ivoclar Vivadent, Inc., with an inspection on January 11, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6edecc43-8729-40b0-9c5a-4773dd87b7fc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037471
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.72(b)Remedial action
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Other FDA inspections of Ivoclar Vivadent, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 7, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 2, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 16, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 9, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 9, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ivoclar Vivadent, Inc.
- FDA Inspection 836298 - 2013-06-07
- FDA Inspection 759584 - 2011-12-02
- FDA Inspection 754457 - 2011-11-16
- FDA Inspection 710802 - 2011-02-09
- FDA Inspection 650681 - 2010-03-09
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