FDA Inspection
Electro-Diagnostic Imaging, Inc.Electro-Diagnostic Imaging, Inc. – FDA Inspection, May 26, 2017
Record Details
This FDA Inspection record concerns Electro-Diagnostic Imaging, Inc., with an inspection on May 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7f9456ae-b31b-4c5f-b7d4-cd438b7993fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1011975
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - software validation documentation
- 21 CFR 820.30(j)Design history file
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Other FDA inspections of Electro-Diagnostic Imaging, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 26, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 3, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 22, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Electro-Diagnostic Imaging, Inc.
- FDA Inspection 837440 - 2013-06-26
- FDA Inspection 752868 - 2011-11-03
- FDA Inspection 651866 - 2010-02-22
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