875423
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 16, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Miami, FL (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14507 | 21 CFR 812.140(a)(3)(ii) | Investigator adverse effect records inadequate |
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2969 | 21 CFR 812.100 | No investigator protection - subject rights, safety, welfare |
| 2970 | 21 CFR 812.100 | Investigator lack of informed consent |
| 2980 | 21 CFR 812.140(a)(1) | Investigator correspondence records inadequate |
| 2981 | 21 CFR 812.140(a)(2)(i) | Investigator device accountability inadequate |
| 7013 | 21 CFR 812.110(d) | Inadequate financial disclosure by investigator |