FDA Inspection 907275 — Vitalant Reference and Transfusion Service
The FDA completed an inspection of Vitalant Reference and Transfusion Service on January 2, 2015 in Chicago, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 2, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 46 | 21 CFR 606.40(a)(6) | Provide space for quarantine of unsuitable for use items |
| 98 | 21 CFR 606.100(c) | Thorough investigations |