Azazuddin A. Ahmed, MD – FDA 483, Nov 8, 2013

An FDA inspection of Dr. Azazuddin Ahmed, a Clinical Investigator in Chicago, revealed significant non-compliance across multiple clinical trials for type 2 diabetes mellitus. Key issues included failures in conducting investigations according to protocol, maintaining adequate drug accountability records, and ensuring timely reporting of serious adverse events. These deficiencies compromised data integrity, subject safety, and overall adherence to regulatory requirements for clinical research.