FDA Inspection 649023 — Immanuel-St Joseph's-Mayo Health System
The FDA completed an inspection of Immanuel-St Joseph's-Mayo Health System on Feb 3, 2010 in Mankato, 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 3, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Mankato, MN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7305 | 21 CFR 56.110(b)(2) | Minor changes |
| 7333 | 21 CFR 56.104(c) | Emergency use and IRB approval |