1079428
Cape Cod Hospital — FEI 1274247
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 15, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Hyannis, MA (United States)
Citations
| ID | CFR | Description |
|---|
| 158 | 21 CFR 606.160(e)(1) | Donor deferral record - each location |
| 18092 | 21 CFR 630.10(f)(6)(ii) | Physical Assessment Determination - Skin Examination |
| 21295 | 21 CFR 211.110(b) | In-process conformity - examination, sample testing |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9256 | 21 CFR 610.41 | Donor Deferral |