FDA Inspection 898684 — Santa Clara Valley Medical Center IRB
The FDA completed an inspection of Santa Clara Valley Medical Center IRB on September 19, 2014 in San Jose, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 19, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- San Jose, CA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7368 | 21 CFR 56.108(a)(2) | More frequent reviews, verification of no changes |
| 7370 | 21 CFR 56.111(c) | Children as subjects |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |