FDA Inspection 646330 — Karen K. Winer, M.D.
The FDA completed an inspection of Karen K. Winer, M.D. on February 3, 2010 in Rockville, MD. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 3, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Rockville, MD (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7411 | 21 CFR 312.53(c)(1) | Investigator statement (FDA 1572) |
| 7479 | 21 CFR 312.56(a) | Monitoring investigations |
| 7480 | 21 CFR 312.50 | Ensuring compliance with plan and protocol |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |