FDA 483 - Ionetix Corporation - January 24, 2022

An FDA inspection of Ionetix Corporation, a sterile PET human drug manufacturer in El Paso, TX, revealed significant deficiencies in their quality system. Observations included a lack of written procedures for handling system suitability failures, inadequate facility controls to prevent product contamination, and a failure to test container closures according to established specifications. These issues indicate a need for improved quality assurance and control practices.