FDA EIR - Azazuddin A. Ahmed, MD - April 30, 2019

An FDA inspection of Dr. Azazuddin A. Ahmed, MD, a clinical investigator at Apex Medical Research, Inc. in Chicago, IL, was conducted from April 16 to April 30, 2019. This inspection, initiated by the Center for Drug Evaluation and Research, aimed to assess compliance with clinical investigation regulations, citing 21 CFR 312.60. Key violations included the failure to conduct investigations in accordance with the investigational plan. A review of 16 subject records revealed that nine were ineligible for the study, failing to meet crucial inclusion or exclusion criteria. Furthermore, subjects were randomized before their medical records were received and reviewed to confirm eligibility. The inspection also cited the failure to prepare and maintain adequate and accurate case histories, notably the absence of essential pre-screening sheets. Discussions during the inspection also highlighted backdated source data and instances of subjects with recent illicit drug use. Dr. Ahmed acknowledged the findings and committed to submitting a written response to the FDA Form 483 by the end of June 2019, outlining implemented corrective actions.