FDA Inspection
Fen Dental Mfg, Inc.Fen Dental Mfg, Inc. – FDA Inspection, Dec 11, 2014
Record Details
This FDA Inspection record concerns Fen Dental Mfg, Inc., with an inspection on December 11, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Fen Dental Mfg, Inc.
- Inspection Date
- December 11, 2014
- Product Type
- Devices
View Company Profile
ID · d52ab51e-539d-4583-8f12-d74c0edea9c4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 906897
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
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 803.17Lack of Written MDR Procedures
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 1, 2017 | VAI | Center for Devices and Radiological Health | Compliance: 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 1032513 - 2017-12-01
- FDA Inspection 674667 - 2010-07-28
- FDA Inspection 578075 - 2009-04-24
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