FDA 483 - University of Wisconsin System Radiopharmaceutical Production Facility

An FDA inspection of University of Wisconsin Radiopharmaceuticals in Madison, WI, revealed critical deficiencies across several areas. The firm failed to maintain adequate controls for electronic records, including lack of backup procedures, user access, and audit trails. Additionally, the inspection identified inadequate aseptic processing controls, such as the use of non-sterile and reused gowning, and a lack of written quality assurance procedures for environmental monitoring investigations.