FDA Inspection 929334 — Debra Carter-Miller
The FDA completed an inspection of Debra Carter-Miller on Jun 11, 2015 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 11, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Indianapolis, IN (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7498 | 21 CFR 312.66 | Unanticipated problems |
| 7517 | 21 CFR 312.66 | Initial and continuing review |
| 7520 | 21 CFR 312.64(b) | Safety reports |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7531 | 21 CFR 312.62(c) | Record retention |
| 7534 | 21 CFR 312.68 | FDA access to clinical investigator records |
| 7543 | 21 CFR 312.61 | Unauthorized recipients (investigator) |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |