702369
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 6, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Holyoke, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9220 | 21 CFR 606.100(b)(21) | Donor notification |