FDA Inspection 627621 — HealthPartners Institute IRB
The FDA completed an inspection of HealthPartners Institute IRB on October 29, 2009 in Bloomington, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 29, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Bloomington, MN (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 |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7337 | 21 CFR 56.115(b) | Retention of records |
| 7369 | 21 CFR 56.109(h) | Children as subjects |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |