FDA Inspection 1178701 — St. Agnes Medical Center IRB
The FDA completed an inspection of St. Agnes Medical Center IRB on Sep 1, 2022 in Fresno, CA. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 1, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Fresno, CA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 2966 | 21 CFR 812.66 | No IRB notification of significant risk determination |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7337 | 21 CFR 56.115(b) | Retention of records |
| 7690 | 21 CFR 56.106(c) | Renewal every 3 years |
| 7693 | 21 CFR 56.106(e) | Changes re: review new products or discontinue reviewing |