FDA Inspection 795606 — Cape Cod Hospital
The FDA completed an inspection of Cape Cod Hospital on Aug 14, 2012 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 14, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Hyannis, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9220 | 21 CFR 606.100(b)(21) | Donor notification |
| 9256 | 21 CFR 610.41 | Donor Deferral |