FDA 483 - Jayant Kumar, M.D. - May 10, 2021

Dr. Jayant Kumar, M.D., a clinical investigator in Albuquerque, NM, was cited for significant deficiencies during an FDA inspection from March to May 2021. The inspection revealed multiple failures in conducting clinical investigations according to protocol, maintaining accurate case histories, promptly reporting serious adverse events, and ensuring adequate investigational drug disposition records. These issues indicate a lack of adherence to regulatory requirements for clinical trials.