1134357
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 17, 2020
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- West Des Moines, IA (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 |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |