FDA Inspection 980790 — Sina Moainie, M.D.
The FDA completed an inspection of Sina Moainie, M.D. on Jul 18, 2016 in Carmel, 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 18, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Carmel, IN (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |