FDA Inspection
Electrical Geodesics, Inc.Electrical Geodesics, Inc. – FDA Inspection, Jun 17, 2016
Record Details
This FDA Inspection record concerns Electrical Geodesics, Inc., with an inspection on June 17, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Electrical Geodesics, Inc.
- Inspection Date
- June 17, 2016
- Product Type
- Devices
View Company Profile
ID · e381d92f-7a89-4cb3-a217-9372e3a28903
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 978919
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.46(a)Sponsor securing investigator compliance
- 21 CFR 812.43(c)(5)No financial disclosure info in investigator agreement
- 21 CFR 812.140(b)(1)Sponsor correspondence records inadequate
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Other FDA inspections of Electrical Geodesics, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 27, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 12, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 12, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Electrical Geodesics, Inc.
- FDA Inspection 920345 - 2015-03-27
- FDA Inspection 674766 - 2010-08-12
- FDA Inspection 674765 - 2010-08-12
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