FDA Inspection 635434 — Mr. Darius F. Mirza
The FDA completed an inspection of Mr. Darius F. Mirza on December 16, 2009 in Birmingham. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 16, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Birmingham (United Kingdom)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7543 | 21 CFR 312.61 | Unauthorized recipients (investigator) |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |
| 7562 | 21 CFR 312.60 | Informed consent |