FDA 483 - Rush University Medical Center Blood Center - March 08, 2019

The FDA inspected Rush University Medical Center Blood Center in Chicago, IL, and issued a Form 483 citing three observations related to quality control and record-keeping. Deficiencies included inadequate approval processes for written procedures and equipment requalification, insufficient documentation for emergency transfusions, and late submission of biological product deviation reports. These findings highlight significant issues in the firm's adherence to regulatory and procedural requirements for blood bank operations.