FDA Inspection 592981 — Edward M. Lane, M.D.
The FDA completed an inspection of Edward M. Lane, M.D. on Jun 10, 2009 in Bridgeport, CT. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 10, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Bridgeport, CT (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7459 | 21 CFR 312.57(a) | Records of receipt, shipment, disposition |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |