Ionetix Corporation – FDA 483, Oct 25, 2019

An FDA inspection of Ionetix Corporation, a PET drug manufacturer in Sarasota, FL, revealed significant deficiencies in their quality assurance procedures and manufacturing controls. The firm failed to establish and follow adequate written procedures for document control, product release, aseptic process validation, and material purchasing. Additionally, issues were noted with incomplete master production records, inadequate equipment qualification and maintenance, and insufficient documentation for laboratory equipment monitoring.