1101197
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 4, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Chicago, IL (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2970 | 21 CFR 812.100 | Investigator lack of informed consent |
| 3021 | 21 CFR 812.150(a)(1) | Investigator report of unanticipated adverse effects |