483
Michael E. Gottschalk, M.D.Michael E. Gottschalk, M.D. – FDA 483, Aug 5, 2022
Record Details
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.
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