FDA Inspection
The Electrode Store IncThe Electrode Store Inc – FDA Inspection, Aug 10, 2009
Record Details
This FDA Inspection record concerns The Electrode Store Inc, with an inspection on August 10, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Electrode Store Inc
- Inspection Date
- August 10, 2009
- Product Type
- Devices
View Company Profile
ID · edfc97bb-a07d-49a8-9ab5-3145d439014f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 610050
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.70(a)Process control procedures
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 |
| July 15, 2011 | 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 734718 - 2011-07-15
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.