FDA Inspection 1164414 — HealthPartners Institute IRB
The FDA completed an inspection of HealthPartners Institute IRB on Mar 14, 2022 in Bloomington, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 14, 2022
- Fiscal Year
- 2022
- 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 |