FDA 483 - Ionetix Corporation - September 26, 2025

Ionetix Corporation, a PET drug manufacturer in Miami Beach, FL, was cited with six observations during an FDA inspection. The observations highlight significant deficiencies in quality assurance, equipment suitability, supplier qualification, facility contamination control, and adherence to written procedures, indicating a lack of robust controls over critical manufacturing and testing processes. These issues could adversely affect the identity, strength, quality, or purity of their PET drug products.