FDA Inspection 661920 — Ascension Sacred Heart Hospital IRB
The FDA completed an inspection of Ascension Sacred Heart Hospital IRB on May 11, 2010 in Pensacola, FL. 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). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 11, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Pensacola, FL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7333 | 21 CFR 56.104(c) | Emergency use and IRB approval |