833281
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 17, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Aurora, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |