1088787
Versiti Blood Health, Inc — FEI 1873403
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 7, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |