FDA Inspection
WR Medical Electronics CompanyWR Medical Electronics Company – FDA Inspection, Jan 19, 2012
Record Details
This FDA Inspection record concerns WR Medical Electronics Company, with an inspection on January 19, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 19, 2012
- Product Type
- Devices
View Company Profile
ID · 3d780501-933a-4836-a7b6-b57a8ecfee16
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 768896
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
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Other FDA inspections of WR Medical Electronics Company
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 22, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 29, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 17, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for WR Medical Electronics Company
- FDA Inspection 1019808 - 2017-06-22
- FDA Inspection 876738 - 2014-04-29
- FDA Inspection 579002 - 2009-04-17
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