FDA Inspection 1087155 — Lauren R. Klein, M.D.
The FDA completed an inspection of Lauren R. Klein, M.D. on Apr 23, 2019 in West Islip, NY. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 23, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- West Islip, NY (United States)
Additional Details
Sponsor-Investigator (S-I)
Citations
| ID | CFR | Description |
|---|---|---|
| 7231 | 21 CFR 50.20 | Consent not obtained, exceptions do not apply |
| 7459 | 21 CFR 312.57(a) | Records of receipt, shipment, disposition |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7552 | 21 CFR 312.66 | Changes in research |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |
| 7638 | 21 CFR 312.20(a) | Failure to submit an IND |