FDA 483 - Ionetix Corporation - July 12, 2019

Ionetix Corporation, a PET drug manufacturer in Kansas City, KS, was cited for three observations during an FDA inspection. The firm lacked adequate production and process controls, specifically regarding media fill simulations for aseptic processing. Additionally, the inspection found failures to follow written quality assurance procedures and deficiencies in laboratory analytical methods, including employee training for visual inspections.