FDA Inspection 771898 — SSM Helathcare St Louis IRB
The FDA completed an inspection of SSM Helathcare St Louis IRB on Mar 6, 2012 in Saint Louis, MO. 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 6, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Saint Louis, MO (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7279 | 21 CFR 56.107(f) | Invited individual allowed to vote with IRB |
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |