FDA 483 - Ionetix Corporation - October 31, 2025

An FDA inspection of Ionetix Corporation, a Positron Emission Tomography (PET) Drug Manufacturer, conducted from October 27 to October 31, 2025, identified multiple deficiencies concerning facility controls, adherence to quality procedures, and production processes. Observations included inadequate facilities for preventing contamination, with organisms detected in critical ISO 5 Laminar Airflow Workstations and insufficient assessment of their impact on product quality. Personnel were also observed failing to follow written quality assurance procedures, specifically regarding proper sterile solution application to forearms and incorrect placement of environmental monitoring settle plates in aseptic areas. Furthermore, the company's production and process controls were found lacking, with deficiencies in the visual inspection procedure for products. These included inconsistent methodology, absence of documented light intensity requirements, and failure to integrate past contamination events into inspection training. Lastly, Ionetix Corporation did not monitor the differential pressure of HEPA filters in ISO 5 laminar airflow workstations, which is critical for verifying air quality. The company is expected to submit a comprehensive plan outlining corrective actions to address these findings and ensure compliance with quality standards for PET drug manufacturing.