FDA Inspection 665756 — Muckerman II, M.D., Richard C.
The FDA completed an inspection of Muckerman II, M.D., Richard C. on May 28, 2010 in Chesterfield, MO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 28, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Chesterfield, MO (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 10005 | n/a | Procedural requirements |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 7231 | 21 CFR 50.20 | Consent not obtained, exceptions do not apply |
| 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 |
| 7562 | 21 CFR 312.60 | Informed consent |