FDA Inspection
Gendex Dental SystemsGendex Dental Systems – FDA Inspection, Oct 8, 2010
Record Details
This FDA Inspection record concerns Gendex Dental Systems, with an inspection on October 8, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gendex Dental Systems
- Inspection Date
- October 8, 2010
- Product Type
- Devices
View Company Profile
ID · b95092c2-12f8-44e6-b9cc-cacb21c0f850
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 695543
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 1002.13Lack of required elements
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 1002.11Failure to submit
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Gendex Dental Systems
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 6, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Gendex Dental Systems
- FDA Inspection 600329 - 2009-05-06
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