1249123
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 12, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Flint, MI (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2981 | 21 CFR 812.140(a)(2)(i) | Investigator device accountability inadequate |
| 2984 | 21 CFR 812.140(a)(3)(i) | Investigator records of informed consent inadequate |
| 3028 | 21 CFR 812.150(a)(4) | No approval for investigator change in non-emergency |
| 7659 | 21 CFR 50.25(a)(6) | Compensation, medical treatment in event of injury |