FDA 483 - Robin Kroll, M.D. - April 23, 2021

Robin Kroll, M.D., a clinical investigator in Seattle, WA, was cited with two observations during an FDA inspection from April 19-23, 2021. The inspection revealed significant failures in conducting an investigational drug study, including not following the protocol, failing to report adverse events, improper investigational product dispensing, and inadequate documentation of case histories and concomitant medications. These issues indicate a lack of adherence to good clinical practice and regulatory requirements for clinical trials.