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FDA Errors - Biological Product Deviation Report

The annual Biological Product Deviation (BPD) Report summarizes reports submitted to Center for Biologics Evaluation and Research (CBER) by licensed manufacturers of blood and blood components, including Source Plasma, and others required by stature to report. Analysis of this information for licensed manufacturers reveals that the largest share of errors derive from the donor health history. The graphs below shows the breakdown of errors for licensed blood establishments for fiscal years 2003-2006.

 
FY 2003
 
FY 2004
 
FY 2005
 
FY 2006
 
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Document last updated 9 January 2009