FDA Inspection
Prime Dental Manufacturing, Inc.Prime Dental Manufacturing, Inc. – FDA Inspection, Dec 22, 2008
Record Details
This FDA Inspection record concerns Prime Dental Manufacturing, Inc., with an inspection on December 22, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 22, 2008
- Product Type
- Devices
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ID · 7e92d365-7009-46c4-9bb2-025e9e912010
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 554863
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(e)(8)Reply to complainant
- 21 CFR 820.70(d)Implementing Personnel Procedures, Health, Cleanliness.
- 21 CFR 820.184(d)Acceptance records
- 21 CFR 820.184(c)Quantity released
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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 |
| December 13, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 25, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Prime Dental Manufacturing, Inc.
- FDA Inspection 1110626 - 2019-11-21
- FDA Inspection 995381 - 2016-12-13
- FDA Inspection 837689 - 2013-06-25
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