FDA 483 - Christine H. Lee, M.D. - June 17, 2022

Christine H. Lee, M.D., a clinical investigator in Victoria, British Columbia, was cited for significant deviations in conducting two investigational new drug studies (2014-01 and 2017-01). The inspection revealed failures in following study protocols, including enrolling ineligible subjects, issues with informed consent, drug misadministration, and inadequate adverse event reporting. These findings indicate serious concerns regarding patient safety and data integrity in clinical trials.