FDA Inspection 677926 — Larry Blankenship
The FDA completed an inspection of Larry Blankenship on August 18, 2010 in Anderson, IN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 18, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Anderson, IN (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7363 | 21 CFR 50.55(f) | Documentation of permission by parents or guardian |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |
| 7498 | 21 CFR 312.66 | Unanticipated problems |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7552 | 21 CFR 312.66 | Changes in research |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |
| 7562 | 21 CFR 312.60 | Informed consent |
| 7664 | 21 CFR 50.20 | Circumstances of obtaining consent |