Ionetix Corporation – FDA 483, Feb 9, 2022

Ionetix Corporation, a PET drug manufacturer in Miami, FL, was cited for significant deficiencies across its quality systems during an FDA inspection. Observations included inadequate contamination prevention in cleanrooms, improper equipment installation affecting airflow, and failures in approving specifications and following quality assurance procedures for material release and expiration dating. These issues indicate a lack of robust controls to ensure product quality and purity.