FDA Inspection
MED-EL Elektromedizinische Gereate, GmbhMED-EL Elektromedizinische Gereate, Gmbh – FDA Inspection, Jun 14, 2012
Record Details
This FDA Inspection record concerns MED-EL Elektromedizinische Gereate, Gmbh, with an inspection on June 14, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 14, 2012
- Product Type
- Devices
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ID · 636539ac-fa35-443d-a399-af6c7fb51f90
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 791656
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of MED-EL Elektromedizinische Gereate, Gmbh
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 7, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 22, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 26, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MED-EL Elektromedizinische Gereate, Gmbh
- FDA Inspection 925871 - 2015-05-07
- FDA Inspection 653048 - 2010-03-22
- FDA Inspection 634572 - 2009-11-26
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