1050930
Ochsner Health System Blood Bank — FEI 2370420
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 4, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- New Orleans, LA (United States)
Citations
| ID | CFR | Description |
|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 251 | 21 CFR 640.25(b) | Quality control |
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9097 | 21 CFR 600.15 | Blood & Blood Components |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 98 | 21 CFR 606.100(c) | Thorough investigations |