FDA 483 - NorthStar Medical Radioisotopes, LLC - August 14, 2019

NorthStar Medical Radioisotopes, LLC, an active pharmaceutical ingredient manufacturer in Columbia, MO, was inspected and cited for significant deficiencies in laboratory controls, manufacturing process monitoring, quality control unit procedures, equipment calibration, and out-of-specification investigations. The observations indicate a systemic failure to ensure product quality and purity, particularly concerning their RadioGenix System and Moly-99 products. These issues led to the distribution of potentially non-conforming products and a lack of assurance regarding patient safety.