FDA Inspection 783754 — Ethical & Independent Review Services, LLC
The FDA completed an inspection of Ethical & Independent Review Services, LLC on April 25, 2012 in San Francisco, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 25, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- San Francisco, CA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 7317 | 21 CFR 56.115(a)(1) | Copies of all research proposals and related documents |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7319 | 21 CFR 56.115(a)(3) | Records of continuing review |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |