FDA Inspection 912827 — Barnes-Jewish Hospital Pheresis Center West
The FDA completed an inspection of Barnes-Jewish Hospital Pheresis Center West on Jan 28, 2015 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). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 28, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 161 | 21 CFR 606.160(a)(2) | Determination of lot numbers and supplies |
| 246 | 21 CFR 640.25(a) | Storage temps./agitation |
| 318 | 21 CFR 640.63(c)(3) | Blood hemoglobin |
| 75 | 21 CFR 606.100(a) | SOP compliance |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 78 | 21 CFR 606.100(c) | Record review prior to release |