483
Loyola Univ Medical CenterFDA 483 - Loyola Univ Medical Center - December 05, 2024
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An FDA inspection of Loyola Univ Medical Center's Hospital Blood Bank in Maywood, IL, revealed two significant observations. The facility failed to maintain concurrent records for manufacturing steps and lacked adequate written standard operating procedures for labeling blood components and completing records. These findings indicate deficiencies in quality control and documentation practices.
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