Ionetix Corporation – FDA 483, Oct 31, 2025

An FDA inspection of Ionetix Corporation, a Positron Emission Tomography Drug Manufacturer in Kansas City, KS, was conducted from October 27 to October 31, 2025. The inspection resulted in an FDA Form 483, detailing several observations regarding deficiencies in Current Good Manufacturing Practices (cGMP).

Key issues included inadequate facility controls to prevent product contamination, specifically the detection of organisms in critical ISO 5 Laminar Airflow Workstations and insufficient assessment of their impact on manufactured batches. Personnel were also observed failing to follow written quality assurance procedures for aseptic technique and environmental monitoring in controlled areas. Furthermore, the firm's production and process controls were found to be lacking, with deficient visual inspection procedures, unclear criteria, and insufficient documentation for light intensity at inspection stations. A contamination event was also not adequately integrated into visual inspection training. Lastly, equipment suitability was questioned due to the absence of differential pressure monitoring for HEPA filters in critical ISO 5 laminar airflow workstations, which could compromise air quality.

Ionetix Corporation is required to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards and maintain product quality and safety.