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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 graph below shows the breakdown of errors for licensed blood establishments for fiscal year 2007. The percentage of errors related to donor history has been approximately 75% for several years (See prior years here). This is the primary reason QDS was developed - to address errors related to donor history.
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