FDA Inspection
Dentsply ProstheticsDentsply Prosthetics – FDA Inspection, Dec 5, 2011
Record Details
This FDA Inspection record concerns Dentsply Prosthetics, with an inspection on December 5, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dentsply Prosthetics
- Inspection Date
- December 5, 2011
- Product Type
- Devices
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ID · c3b0e29e-19b2-4b99-851f-5878eb351312
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 755055
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Dentsply Prosthetics
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 23, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Dentsply Prosthetics
- FDA Inspection 927058 - 2015-05-22
- FDA Inspection 598909 - 2009-07-23
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