FDA Inspection
Fen Dental Mfg, Inc.Fen Dental Mfg, Inc. – FDA Inspection, Apr 24, 2009
Record Details
This FDA Inspection record concerns Fen Dental Mfg, Inc., with an inspection on April 24, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Fen Dental Mfg, Inc.
- Inspection Date
- April 24, 2009
- Product Type
- Devices
View Company Profile
ID · ac181647-4043-4af3-8233-b298cdfc55e0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 578075
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.72(b)(2)Calibration documentation
- 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 |
| 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 |
Other documents for Fen Dental Mfg, Inc.
- FDA Inspection 1032513 - 2017-12-01
- FDA Inspection 906897 - 2014-12-11
- FDA Inspection 674667 - 2010-07-28
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