FDA Inspection 732397 — CHRISTUS St Frances Cabrini Hospital Institutional Review Bo
The FDA completed an inspection of CHRISTUS St Frances Cabrini Hospital Institutional Review Bo on Jun 24, 2011 in Alexandria, LA. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 24, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Alexandria, LA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7320 | 21 CFR 56.109(e) | IRB approvals/disapprovals - general |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |