FDA Inspection 867058 — BayCare Health Systems IRB
The FDA completed an inspection of BayCare Health Systems IRB on Feb 13, 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 13, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Clearwater, FL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7277 | 21 CFR 56.107(d) | One non-affiliate member |
| 7334 | 21 CFR 56.115(a)(5) | List of members |