FDA Inspection
Keystone Dental IncKeystone Dental Inc – FDA Inspection, Jun 8, 2017
Record Details
This FDA Inspection record concerns Keystone Dental Inc, with an inspection on June 8, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f554cbb8-a6e4-4fa8-a6d6-d79b7f60a2df
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014229
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Keystone Dental Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 7, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 12, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Keystone Dental Inc
- FDA Inspection 851881 - 2013-10-07
- FDA Inspection 797857 - 2012-10-12
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