FDA Inspection 906361 — William W. Storms, M.D., Clinical Investigator
The FDA completed an inspection of William W. Storms, M.D., Clinical Investigator on October 27, 2014 in Colorado Springs, CO. 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: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 27, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Colorado Springs, CO (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7498 | 21 CFR 312.66 | Unanticipated problems |
| 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 |