FDA 483 - Michael E. Gottschalk, M.D. - August 05, 2022

An FDA inspection of Michael E. Gottschalk, M.D., a clinical investigator in San Diego, revealed significant deviations from the investigational plan. Observations included incorrect subject randomization, incomplete physical examinations, missed study visits, and out-of-window visit conduct. Additionally, the firm failed to maintain adequate and accurate case histories, specifically regarding the reporting of adverse events and concomitant medications in eCRFs.