FDA 483 - Loyola Univ Medical Center - December 05, 2024

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.