FDA Inspection 715430 — Barnes-Jewish Hospital Blood Bank
The FDA completed an inspection of Barnes-Jewish Hospital Blood Bank on Mar 15, 2011 in Saint Louis, MO. 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). 8 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 15, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 163 | 21 CFR 606.165(b) | Distribution records - content |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |
| 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 |
| 98 | 21 CFR 606.100(c) | Thorough investigations |