FDA 483 - Ionetix Corporation - May 01, 2025

Ionetix Corporation in Miami, FL, a PET drug manufacturer, was cited for significant deficiencies in facility control, equipment maintenance, laboratory methods, and quality systems during an FDA inspection. The observations highlight issues with contamination prevention in cleanrooms, inadequate equipment setup, conflicting environmental monitoring procedures, insufficient corrective actions for sterility failures, and lack of proper resources for QC personnel, with several issues being repeat observations.