FDA Inspection 1095744 — Avera IRB
The FDA completed an inspection of Avera IRB on July 10, 2019 in Sioux Falls, SD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 10, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Sioux Falls, SD (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7320 | 21 CFR 56.109(e) | IRB approvals/disapprovals - general |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7337 | 21 CFR 56.115(b) | Retention of records |
| 7652 | 21 CFR 56.113 | Reporting |
| 7683 | 21 CFR 56.106(b)(2) | IRB registration information |
| 7692 | 21 CFR 56.106(e) | Changes in contact or chairperson information |