FDA Inspection 1090898 — HealthPartners Institute IRB
The FDA completed an inspection of HealthPartners Institute IRB on May 28, 2019 in Bloomington, MN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 28, 2019
- Fiscal Year
- 2019
- 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 |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7337 | 21 CFR 56.115(b) | Retention of records |
| 7353 | 21 CFR 50.52 | Factors required for approval |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |
| 7652 | 21 CFR 56.113 | Reporting |
| 7683 | 21 CFR 56.106(b)(2) | IRB registration information |
| 7694 | 21 CFR 56.106(e) | Decison to disband IRB |