FDA Inspection 845879 — St Vincent Health
The FDA completed an inspection of St Vincent Health on August 26, 2013 in Indianapolis, IN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 26, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Indianapolis, IN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7369 | 21 CFR 56.109(h) | Children as subjects |