FDA Inspection 585985 — Deitz, M.D., Robert
The FDA completed an inspection of Deitz, M.D., Robert on May 28, 2009 in San Francisco, CA. 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
- May 28, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- San Francisco, CA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7520 | 21 CFR 312.64(b) | Safety reports |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7531 | 21 CFR 312.62(c) | Record retention |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |
| 7562 | 21 CFR 312.60 | Informed consent |