FDA Inspection
Coltene /Whaledent AGColtene /Whaledent AG – FDA Inspection, Dec 9, 2010
Record Details
This FDA Inspection record concerns Coltene /Whaledent AG, with an inspection on December 9, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Coltene /Whaledent AG
- Inspection Date
- December 9, 2010
- Product Type
- Devices
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ID · 6ba035fd-18cf-4ad7-abda-021bbda335b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 704248
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Coltene /Whaledent AG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Coltene /Whaledent AG
- FDA Inspection 849198 - 2013-09-19
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