Ionetix Corporation – FDA 483, Apr 2, 2026

Ionetix Corporation, a Positron Emission Tomography Drug Manufacturer in Sarasota, FL, was cited for four observations during an FDA inspection. The findings include issues with equipment suitability and maintenance, use of an unreliable component supplier, lack of approved specifications for materials, and deviations from written production and process control procedures. These deficiencies indicate potential risks to the identity, strength, quality, and purity of PET drugs.