715524
Walter L. Shepeard Community Blood Center, Inc. — FEI 1046616
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 23, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Augusta, GA (United States)
Citations
| ID | CFR | Description |
|---|
| 143 | 21 CFR 606.140(b) | Provisions to monitor lab test procedures & instruments |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |
| 9235 | 21 CFR 630.40(c) | Documentation |
| 9240 | 21 CFR 630.40(d)(1) | Physician notification |
| 98 | 21 CFR 606.100(c) | Thorough investigations |