FDA 483 - Ionetix Corporation - September 22, 2023

An FDA inspection of Ionetix Corporation in Knoxville, TN, a PET drug manufacturer, revealed significant deficiencies across multiple systems. Observations included a lack of adequate procedures for equipment operation and maintenance, insufficient trained personnel for cyclotron operations, and improper handling and storage of components, specifically unlabeled vials. These issues indicate a potential risk to the identity, strength, quality, or purity of PET drugs produced at the facility.