1097388
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 24, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Innsbruck (Austria)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |