FDA 483 - University of Wisconsin System Radiopharmaceutical Production Facility - May 23, 2019

The FDA inspected the Univ. of Wisconsin Radiopharmaceutical Production Facility in Madison, WI, a PET drug manufacturer. The inspection revealed significant deficiencies in method validation, quality control of supplies, and production and process controls, particularly concerning aseptic operations and environmental monitoring. These issues indicate a lack of assurance in the identity, strength, quality, and purity of their PET drug products.