FDA Inspection
Prime Dental Manufacturing, Inc.Prime Dental Manufacturing, Inc. – FDA Inspection, Dec 13, 2016
Record Details
This FDA Inspection record concerns Prime Dental Manufacturing, Inc., with an inspection on December 13, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e3f80a3a-e6db-446b-ab4d-749af9d96585
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 995381
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Prime Dental Manufacturing, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 25, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 22, 2008 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Prime Dental Manufacturing, Inc.
- FDA Inspection 1110626 - 2019-11-21
- FDA Inspection 837689 - 2013-06-25
- FDA Inspection 554863 - 2008-12-22
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