FDA Inspection
MED-EL Elektromedizinische Gereate, GmbhMED-EL Elektromedizinische Gereate, Gmbh – FDA Inspection, May 7, 2015
Record Details
This FDA Inspection record concerns MED-EL Elektromedizinische Gereate, Gmbh, with an inspection on May 7, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 7, 2015
- Product Type
- Devices
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ID · f3caf7b8-24c3-4759-8c09-309ad1251ec8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 925871
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 803.50(a)(2)Individual Report of Malfunction
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Other FDA inspections of MED-EL Elektromedizinische Gereate, Gmbh
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 791656 - 2012-06-14
- FDA Inspection 653048 - 2010-03-22
- FDA Inspection 634572 - 2009-11-26
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