Ionetix Corporation – FDA 483, Sep 26, 2025

From September 22-26, 2025, the FDA conducted an inspection of Ionetix Corporation, a Positron Emission Tomography (PET) Manufacturer, and issued a Form 483 citing significant deviations from current Good Manufacturing Practices (cGMP) for PET drugs. Key observations spanned quality systems, equipment management, and facility controls.

The main violations included a failure to follow written procedures for supplier qualification, specifically using an unregistered vendor for a critical reagent in numerous patient and validation batches. Equipment suitability issues were identified, such as obstructions compromising an ISO 5 laminar flow hood's integrity, and a lack of emergency procedures for power outages that could affect cyclotron magnet functionality. Furthermore, the company did not adhere to testing procedures, notably by failing to provide required shielding during radiochemical purity testing. Facility inadequacies included the storage of particle-generating items in cleanrooms, insufficient investigation of microbial contamination (e.g., Bacillus spp. in an ISO 5 hood) identified during environmental monitoring, and the absence of procedures for sporicidal sanitization in response to such findings. Ionetix Corporation is required to implement comprehensive corrective and preventive actions to address these observations, ensuring compliance and safeguarding product quality and patient safety.