Company
United StatesGendex Dental Systems, Des Plaines, IL – FDA Inspections
Inspection records and compliance data for Gendex Dental Systems in Des Plaines, Illinois. 2 FDA inspections on record, last inspected October 08, 2010.
Company Profile
This profile covers Gendex Dental Systems based in Des Plaines, Illinois, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected May 6, 2009. Last inspected October 8, 2010.
Most cited issue areas
- DHR - not or inadequately maintained1 inspection
- Failure to submit1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 8, 2010 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 695543 |
| May 6, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 600329 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Gendex Dental Systems
FEI Number
3004115000
Address
901 W Oakton St, Des Plaines, Illinois 60018, United States
Country
United States
ID: 371ed051-d1bc-4f49-a431-e206b6fb3490