714457
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 16, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Jackson, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 81 | 21 CFR 606.100(b)(2) | Donor qualifying tests & measurements |