FDA Inspection
The Electrode Store IncThe Electrode Store Inc – FDA Inspection, Jul 15, 2011
Record Details
This FDA Inspection record concerns The Electrode Store Inc, with an inspection on July 15, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Electrode Store Inc
- Inspection Date
- July 15, 2011
- Product Type
- Devices
View Company Profile
ID · f057f72e-4758-45fd-ba62-8b9780ed0122
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 734718
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of The Electrode Store Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 25, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 20, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 20, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 10, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for The Electrode Store Inc
- FDA Inspection 905905 - 2014-11-25
- FDA Inspection 807773 - 2012-11-20
- FDA Inspection 794901 - 2012-08-20
- FDA Inspection 610050 - 2009-08-10
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