FDA Inspection 807438 — Agnesian Healthcare IRB
The FDA completed an inspection of Agnesian Healthcare IRB on November 13, 2012 in Fond Du Lac, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 13, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Fond Du Lac, WI (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7297 | 21 CFR 56.109(b) | Information given to subjects |
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 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 |
| 7320 | 21 CFR 56.109(e) | IRB approvals/disapprovals - general |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |