ImmunoGen, Inc. – FDA EIR, Jul 28, 2022

ImmunoGen, Inc. underwent a high-priority FDA inspection from July 20-28, 2022, focusing on its sponsor responsibilities for clinical study protocol IMGN853 (SORAYA), conducted under IND 111915 and BLA 761310. This was ImmunoGen's first FDA inspection, requested by the Office of Scientific Investigations. The primary issue identified was that not all protocol deviations logged by the firm were included in the data listings submitted to the FDA with the Clinical Study Report. Specifically, six major and fourteen minor protocol deviations were erroneously omitted. This failure stemmed from inadequate input masks and edit checks in the Contract Research Organization's (CRO) clinical trial management system (CTMS), oversight failures in programming, and a lapse in ImmunoGen's Quality Assurance (QA) 100% review of reported deviations against the log, as required by their standard operating procedure. ImmunoGen confirmed these omissions and has initiated a Quality Issue within its Quality Management System, actively working to determine and implement appropriate corrective and preventive actions. Preliminary discussions with the CRO have also taken place. The inspection, conducted under Compliance Program 7348.810, evaluated various aspects including investigator selection, monitoring, safety reporting, data handling, and electronic records. The company affirmed its commitment to addressing the identified data integrity concerns to ensure compliance with regulatory standards.