FDA Inspection 865778 — Barnes-Jewish Hospital Blood Bank
The FDA completed an inspection of Barnes-Jewish Hospital Blood Bank on February 6, 2014 in Saint Louis, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 6, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 253 | 21 CFR 640.25(b)(4) | Corrective action |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 92 | 21 CFR 606.100(b)(13) | Procedures to relate blood from donor to final disposition |
| 9225 | 21 CFR 606.171 | Biological product deviation report |