FDA 483 - Isomedix Operations, Inc. - September 18, 2023

Isomedix Operations Inc., a radiation sterilization facility in Libertyville, Illinois, was inspected by the FDA from September 11-18, 2023. The inspection highlighted several critical observations indicating non-adherence to regulatory requirements under the Federal Food, Drug, and Cosmetic Act. Key issues included the quality control unit failing to follow written procedures, specifically the improper discarding of original processing records. The firm also neglected to define operational qualification intervals and perform periodic verification for a Gamma Irradiator, contrary to its own equipment maintenance protocols. Furthermore, there was an absence of adequate production and process controls, evidenced by the uncontrolled issuance of electronic processing records without quality department oversight. Lastly, the company's investigations into discrepancies were insufficient; an investigation into the use of expired verification dosimeters did not extend to assessing all drug products irradiated during the affected period. Isomedix Operations Inc. is now required to address these observations and implement comprehensive corrective actions to ensure full compliance with regulatory standards.