FDA Inspection
Electro-Diagnostic Imaging, Inc.Electro-Diagnostic Imaging, Inc. – FDA Inspection, Feb 22, 2010
Record Details
This FDA Inspection record concerns Electro-Diagnostic Imaging, Inc., with an inspection on February 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 22, 2010
- Product Type
- Devices
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ID · d49dba8f-8d76-4368-9341-3c05d0045aec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 651866
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.180(b)Retention period
- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Electro-Diagnostic Imaging, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 26, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 |
Other documents for Electro-Diagnostic Imaging, Inc.
- FDA Inspection 1011975 - 2017-05-26
- FDA Inspection 837440 - 2013-06-26
- FDA Inspection 752868 - 2011-11-03
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