FDA 483 - Saima Jehangir, M.D. - February 25, 2022

An FDA inspection of Saima Jehangir, MD, a Clinical Investigator in Austin, TX, revealed significant deviations from clinical investigation protocols. The firm failed to conduct required study visits and tests for multiple subjects and did not obtain the most recent informed consent from subjects prior to drug administration and study-related tests. These findings indicate serious non-compliance with regulatory requirements for human subject protection and clinical trial conduct.