1216054
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 25, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Waterford Township, MI (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14508 | 21 CFR 812.140(a)(4) | Investigator record of protocol deviations inadequate |
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2970 | 21 CFR 812.100 | Investigator lack of informed consent |
| 2980 | 21 CFR 812.140(a)(1) | Investigator correspondence records inadequate |
| 2985 | 21 CFR 812.140(a)(3)(ii) | Investigator records of relevant observations inadequate |