FDA Inspection
Ivoclar Vivadent Manufacturing, Inc.Ivoclar Vivadent Manufacturing, Inc. – FDA Inspection, Sep 20, 2017
Record Details
This FDA Inspection record concerns Ivoclar Vivadent Manufacturing, Inc., with an inspection on September 20, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 92ee736c-1388-4f8c-81fd-045213887900
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1025860
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.184DHR content
- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ivoclar Vivadent Manufacturing, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 11, 2018 | Not classified | New Jersey District Office | |
| November 22, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 21, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ivoclar Vivadent Manufacturing, Inc.
- FDA Inspection 1121013 - 2018-10-11
- FDA Inspection 754045 - 2011-11-22
- FDA Inspection 557929 - 2009-01-21
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