FDA Inspection 715524 — Walter L. Shepeard Community Blood Center, Inc.
The FDA completed an inspection of Walter L. Shepeard Community Blood Center, Inc. on Mar 23, 2011 in Augusta, GA. 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). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 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 |