Gustavo Vasili Lucas, MD – FDA 483

Gustavo Vasili Lucas, MD, a clinical investigator in Curitiba, Brazil, was cited for failing to prepare and maintain adequate case histories during a clinical investigation. The inspection revealed significant deficiencies in documenting critical data related to serum sample processing and adherence to investigational product administration protocols. These issues indicate a serious lack of proper record-keeping and protocol compliance in clinical trial conduct.