FDA 483 - Ionetix Corporation - September 14, 2023

Ionetix Corporation in El Paso, TX, a PET drug manufacturer, was cited with two observations during an FDA inspection from September 11-14, 2023. The inspection revealed inadequate facility controls for contamination prevention, specifically lacking viable surface sampling in an ISO 5 hood, and deficiencies in laboratory testing procedures, including unvalidated incubation conditions for environmental and personnel monitoring media. These issues indicate potential risks to product quality and purity.