FDA 483 - The University of Utah DBA Cyclotron Radiochemistry Lab, Huntsman Cancer Institute - September 06, 2024

The University of Utah DBA Cyclotron Radiochemistry Lab, a PET Drug Manufacturer in Salt Lake City, UT, was cited for failing to follow its written quality assurance procedures. Specifically, the firm did not perform annual product reviews for Pylarify Injection and did not complete or timely sign off on reviews for FDG Fludeoxyglucose F18 Injection as required by its own SOP. This indicates a significant lapse in maintaining quality system compliance for its radiopharmaceutical drug manufacturing.