FDA Inspection 631284 — Centracare St. Cloud Hospital - Irb
The FDA completed an inspection of Centracare St. Cloud Hospital - Irb on Dec 2, 2009 in Saint Cloud, MN. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 2, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Saint Cloud, MN (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 |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |