FDA Inspection
Fen Dental Mfg, Inc.Fen Dental Mfg, Inc. – FDA Inspection, Dec 1, 2017
Record Details
This FDA Inspection record concerns Fen Dental Mfg, Inc., with an inspection on December 1, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f1874c34-d418-4acd-b218-0507f80359fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1032513
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 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 Fen Dental Mfg, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 28, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 24, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Fen Dental Mfg, Inc.
- FDA Inspection 906897 - 2014-12-11
- FDA Inspection 674667 - 2010-07-28
- FDA Inspection 578075 - 2009-04-24
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