FDA Inspection
Cosmedent, Inc.Cosmedent, Inc. – FDA Inspection, Feb 24, 2014
Record Details
This FDA Inspection record concerns Cosmedent, Inc., with an inspection on February 24, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cosmedent, Inc.
- Inspection Date
- February 24, 2014
- Product Type
- Devices
View Company Profile
ID · 0b42168b-cd3d-46b9-9b94-9e3ef20f697a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 865876
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(c)Management review dates
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cosmedent, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 7, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 10, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 10, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 11, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cosmedent, Inc.
- FDA Inspection 1016866 - 2017-06-07
- FDA Inspection 723034 - 2011-03-10
- FDA Inspection 713377 - 2011-03-10
- FDA Inspection 596468 - 2009-06-11
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