FDA 483 - Hagop M. Kantarjian, M.D. - May 05, 2017

An FDA inspection of Hagop M. Kantarjian, M.D. in Houston, TX, identified significant deficiencies in the conduct of clinical trials. Observations included the improper documentation of informed consent, where forms were not dated by subjects, and the failure to report adverse experiences to the study sponsor in a timely manner as required by protocol and regulations.