FDA Inspection 1019756 — Maura N. Dickler, MD
The FDA completed an inspection of Maura N. Dickler, MD on Jul 27, 2017 in New York, NY. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 27, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- New York, NY (United States)
Additional details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7520 | 21 CFR 312.64(b) | Safety reports |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7534 | 21 CFR 312.68 | FDA access to clinical investigator records |