FDA Inspection 796610 — Bellin Health System Inc., IRB
The FDA completed an inspection of Bellin Health System Inc., IRB on July 25, 2012 in Green Bay, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 25, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Green Bay, WI (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |