FDA Inspection 882213 — Cape Cod Healthcare IRB
The FDA completed an inspection of Cape Cod Healthcare IRB on Jun 5, 2014 in West Yarmouth, MA. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 5, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- West Yarmouth, MA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7380 | 21 CFR 50.27(b)(2) | Short form: IRB approval of oral presentation |