FDA Inspection 893385 — Solutions IRB LLC
The FDA completed an inspection of Solutions IRB LLC on Aug 15, 2014 in Yarnell, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 15, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Yarnell, AZ (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 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 |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7326 | 21 CFR 56.111(a)(6) | Monitoring of data collected |
| 7339 | 21 CFR 56.108(a)(4) | Changes in approved research |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |