FDA Inspection
Keystone Dental IncKeystone Dental Inc – FDA Inspection, Oct 12, 2012
Record Details
This FDA Inspection record concerns Keystone Dental Inc, with an inspection on October 12, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Keystone Dental Inc
- Inspection Date
- October 12, 2012
- Product Type
- Devices
View Company Profile
ID · 34e48030-3c9c-4193-a3dc-c6df717daff8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 797857
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Keystone Dental Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 8, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 7, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Keystone Dental Inc
- FDA Inspection 1014229 - 2017-06-08
- FDA Inspection 851881 - 2013-10-07
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