FDA 483 - ISORX CYCLOTRON CENTER - March 13, 2026

From March 9 to March 13, 2026, the FDA conducted an inspection of Isorx Cyclotron Center, a radiopharmaceutical manufacturer located in Lubbock, Texas. The inspection identified several critical failures in the facility"s adherence to the Federal Food, Drug, and Cosmetic Act, particularly regarding production and quality systems. The primary violations centered on a lack of standardized manufacturing controls. Investigators found that the facility failed to establish clear limits for production yields or reconcile manufacturing inputs, resulting in inconsistent product quality. Furthermore, the firm used expired reagents in drug production without documenting these errors. Labeling practices were also found to be unreliable, with multiple instances of missing or incorrect information regarding product activity and expiration times. Environmental monitoring within the cleanrooms was significantly deficient. The company failed to perform routine microbial testing for nearly two years and did not adequately investigate reported equipment failures or microbial contamination. Physical inspections of the sterile areas revealed structural gaps, rust, and improper sealing, which could compromise the manufacturing environment. Additionally, the quality system lacked oversight, as staff were not properly trained in standardized documentation or pharmaceutical manufacturing principles. Many corrective action plans remained unfinished or poorly tracked. While these observations do not constitute a final regulatory determination, Isorx Cyclotron Center is expected to address these deficiencies. The company must implement comprehensive corrective actions and may submit a formal response to the FDA detailing its plan to bring operations into compliance with safety and quality standards.