FDA Inspection 1081962 — Rush University Medical Center Blood Center
The FDA completed an inspection of Rush University Medical Center Blood Center on Mar 8, 2019 in Chicago, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 8, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 150 | 21 CFR 606.151(e) | Procedures to maintain records of emergency transfusions |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 9225 | 21 CFR 606.171 | Biological product deviation report |