FDA Inspection 1083450 — Seton Family of Hospitals Institutional Review Board (SFOH IRB)
The FDA completed an inspection of Seton Family of Hospitals Institutional Review Board (SFOH IRB) on March 22, 2019 in Austin, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 22, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Austin, TX (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7337 | 21 CFR 56.115(b) | Retention of records |
| 7369 | 21 CFR 56.109(h) | Children as subjects |