594930
Versiti Blood Health, Inc — FEI 1873403
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 19, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 3453 | 21 CFR 601.12(c) | Moderate changes to an approved application |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9225 | 21 CFR 606.171 | Biological product deviation report |