FDA Inspection 825609 — Mother Frances Hospital IRB
The FDA completed an inspection of Mother Frances Hospital IRB on April 2, 2013 in Tyler, 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 2, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Tyler, TX (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |