FDA Inspection 868214 — BayCare Health Systems IRB
The FDA completed an inspection of BayCare Health Systems IRB on Feb 19, 2014 in Clearwater, 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 19, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Clearwater, FL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7392 | 21 CFR 50.25(a)(7) | Whom to contact |
| 7652 | 21 CFR 56.113 | Reporting |