FDA Inspection 1079428 — Cape Cod Hospital
The FDA completed an inspection of Cape Cod Hospital on Feb 15, 2019 in Hyannis, 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 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 |