FDA Inspection
UPMC Horizon - GreenvilleUPMC Horizon - Greenville – FDA Inspection, Jul 30, 2009
Record Details
This FDA Inspection record concerns UPMC Horizon - Greenville, with an inspection on July 30, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- UPMC Horizon - Greenville
- Inspection Date
- July 30, 2009
- Product Type
- Biologics
View Company Profile
ID · c1814358-847d-4a2b-a4d3-7875d01ace1d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 599816
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.151(e)Procedures to maintain records of emergency transfusions
- 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 UPMC Horizon - Greenville
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 31, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for UPMC Horizon - Greenville
- FDA Inspection 816296 - 2013-01-30
- FDA Inspection 707046 - 2011-01-31
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.