483
Rush University Medical Center Blood CenterFDA 483 - Rush University Medical Center Blood Center - June 20, 2008
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Record Details
An FDA inspection of Rush University Medical Center Blood Center in Chicago, IL, revealed two significant observations. The facility failed to submit multiple biological product deviation reports within the required 45-day timeframe. Additionally, the blood center did not perform thorough investigations or maintain adequate records for unexplained discrepancies, including instances of blood product mistyping.
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