1176004
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 29, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Jeffersonville, IN (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 3021 | 21 CFR 812.150(a)(1) | Investigator report of unanticipated adverse effects |