FDA 483 - Jean F. Botha, M.D. - February 07, 2025

An FDA inspection of Jean F. Botha, M.D., a clinical investigator in Murray, UT, revealed significant deviations from the investigational plan. The firm failed to reconsent subjects with updated informed consent versions and did not conduct required direct patient contact visits as stipulated by an amended Clinical Investigation Plan. These issues indicate a lack of adherence to study protocols and subject protection.