FDA 483 - George R. Thompson, M.D. - October 17, 2022

George R. Thompson, M.D., a clinical investigator in Sacramento, CA, received a Form 483 with two observations following an FDA inspection. The inspection revealed that investigations were not conducted according to the investigational plan, specifically concerning the enrollment of subjects who did not meet inclusion or exclusion criteria. Additionally, the firm failed to obtain proper informed consent from human subjects prior to study procedures and drug administration, including issues with the timing of consent and the availability of translated forms.