FDA Inspection 1103421 — Roger S. Keresztes, M.D.
The FDA completed an inspection of Roger S. Keresztes, M.D. on Sep 27, 2019 in Stony Brook, 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
- Sep 27, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Stony Brook, NY (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 |
| 7562 | 21 CFR 312.60 | Informed consent |