FDA EIR - RadioMedix, Inc. - February 16, 2024

An FDA Pre-Approval Inspection (PAI) was conducted at RadioMedix, Inc.'s Humble, TX facility from February 12-16, 2024. The inspection, requested by the FDA Office of Pharmaceutical Quality Operations, aimed to assess the company's readiness for manufacturing new Positron Emission Tomography (PET) drug applications, ensure conformance to application details, and verify data integrity. This followed a previous PAI in 2022 that resulted in an Official Action Indicated (OAI) classification with multiple observations related to production controls and quality systems. During the current inspection, RadioMedix was issued a Form FDA 483, identifying three significant observations. Firstly, the company failed to ensure generators were labeled with an appropriate shelf-life prior to distribution, despite stability data indicating failures at the six-month mark for a product labeled with a 12-month shelf-life. This highlights an issue with overseeing production operations to ensure product quality and purity, citing 21 CFR 212.20(a). Secondly, the inspection found a failure to adequately determine root causes and implement corrective actions for stability failure investigations. Lastly, the company did not ensure sufficient contact time for disinfectants used in its cleanroom facility, potentially compromising environmental control. RadioMedix's management committed to responding to the observations within 15 business days.