FDA 483 - Ionetix Corporation - June 04, 2021

An FDA inspection of Ionetix Corp in Pittsburgh, PA, a PET drug establishment, revealed two significant observations. The firm lacked adequate production and process controls to ensure consistent production of a sterile injectable PET drug, specifically regarding environmental monitoring during aseptic processing. Additionally, the facilities were deemed inadequate to prevent contamination, with a lack of supporting data for environmental monitoring plate usage.