FDA Inspection 932433 — Thomas S. Tooma, M.D.
The FDA completed an inspection of Thomas S. Tooma, M.D. on July 17, 2015 in Newport Beach, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 17, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Newport Beach, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7363 | 21 CFR 50.55(f) | Documentation of permission by parents or guardian |
| 7411 | 21 CFR 312.53(c)(1) | Investigator statement (FDA 1572) |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7488 | 21 CFR 312.59 | Records of unused drug 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 |
| 7632 | 21 CFR 312.6(a) | Required label statement |
| 7638 | 21 CFR 312.20(a) | Failure to submit an IND |