FDA Inspection 925871 — MED-EL Elektromedizinische Gereate, Gmbh
The FDA completed an inspection of MED-EL Elektromedizinische Gereate, Gmbh on May 7, 2015 in Innsbruck. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 7, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Innsbruck (Austria)
Citations
| ID | CFR | Description |
|---|---|---|
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |