FDA 483 - Devalingam Mahalingam, M.D., Ph.D. - October 18, 2024

An FDA inspection of Devalingam Mahalingam, M.D., Ph.D. in Chicago, IL, a clinical investigator, revealed significant deficiencies in clinical trial conduct. Observations included a failure to properly investigate a serious adverse event involving an investigational drug overdose that led to a subject's death. Additionally, the inspection found multiple instances where short form informed consent documents lacked required witness signatures for non-English speaking subjects.