483
Loyola Univ Medical CenterFDA 483 - Loyola Univ Medical Center - December 05, 2024
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Loyola Univ Medical Center in Maywood, IL, a hospital blood bank, was inspected by the FDA from December 3-5, 2024. The inspection revealed issues with concurrent record-keeping during product manufacturing and a lack of established written standard operating procedures for processing blood and blood components. These observations indicate deficiencies in quality system controls related to documentation and procedural adherence.
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