FDA Inspection
Barnes-Jewish Hospital Pheresis Center WestBarnes-Jewish Hospital Pheresis Center West – FDA Inspection, Jan 28, 2015
Record Details
This FDA Inspection record concerns Barnes-Jewish Hospital Pheresis Center West, with an inspection on January 28, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 28, 2015
- Product Type
- Biologics
View Company Profile
ID · eae70b7b-fe44-4e6d-8c37-fe3dbe49a013
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 912827
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 606.160(a)(2)Determination of lot numbers and supplies
- 21 CFR 640.63(c)(3)Blood hemoglobin
- 21 CFR 606.100(a)SOP compliance
- 21 CFR 640.25(a)Storage temps./agitation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Barnes-Jewish Hospital Pheresis Center West
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 12, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Barnes-Jewish Hospital Pheresis Center West
- FDA Inspection 809564 - 2012-12-05
- FDA Inspection 707012 - 2011-01-12
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.