FDA Inspection 981967 — Kang Zhang, M.D., Ph.D.
The FDA completed an inspection of Kang Zhang, M.D., Ph.D. on August 1, 2016 in La Jolla, CA. 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
- August 1, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- La Jolla, CA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7479 | 21 CFR 312.56(a) | Monitoring investigations |
| 7517 | 21 CFR 312.66 | Initial and continuing review |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7531 | 21 CFR 312.62(c) | Record retention |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |
| 7629 | 21 CFR 312.56(c) | Annual report |
| 7695 | 21 CFR 50.25(c) | ClincialTrials.gov statement |