829171
Community Blood Bank of Erie County — FEI 2572105
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 26, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Erie, PA (United States)
Citations
| ID | CFR | Description |
|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 236 | 21 CFR 640.5(e) | Testing - inspection |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9596 | 21 CFR 640.3(a) | Donor suitability by means of medical history |
| 98 | 21 CFR 606.100(c) | Thorough investigations |