FDA 483 - International Isotopes Inc. - April 25, 2025

International Isotopes Inc. in Idaho Falls, ID, a radiopharmaceutical drug manufacturer, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate investigations into product discrepancies and complaints, issues with the accuracy and reproducibility of test methods for radiochemical purity, and a lack of adequately trained and experienced personnel within the Quality Unit. These issues indicate a systemic breakdown in quality control and assurance processes.