FDA 483 - University of Southern California, DBA USC Molecular Imaging Center - August 14, 2019

The FDA inspected the University of Southern California, DBA USC Molecular Imaging Center, a PET Drug Manufacturer, from August 6-14, 2019. The inspection revealed significant deficiencies across multiple areas, including unsuitable laboratory analytical methods, incomplete test records, failure to investigate out-of-specification results, inadequate production controls, and non-adherence to quality assurance procedures and equipment calibration protocols. Several observations were noted as repeat findings, indicating persistent issues with the firm's quality systems.