Company
AustriaMED-EL Elektromedizinische Gereate, Gmbh, Innsbruck, Austria – FDA Inspections
Inspection records and compliance data for MED-EL Elektromedizinische Gereate, Gmbh in Innsbruck. 4 FDA inspections on record, last inspected May 07, 2015.
Company Profile
This profile covers MED-EL Elektromedizinische Gereate, Gmbh based in Innsbruck, Austria.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected November 26, 2009. Last inspected May 7, 2015.
Most cited issue areas
- Environmental control Lack of or inadequate procedures1 inspection
- Individual Report of Malfunction1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 7, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 925871 |
| June 14, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 791656 |
| March 22, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 653048 |
| November 26, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 634572 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
MED-EL Elektromedizinische Gereate, Gmbh
FEI Number
3000249315
Address
Furstenweg 77a, Innsbruck, Austria
Country
Austria
ID: 9de445e0-150e-4574-a05d-db796169a5cf