FDA 483 - William J. Gradishar, M.D. - February 28, 2020

William J. Gradishar, M.D., a clinical investigator in Chicago, IL, was cited for two observations during an FDA inspection. The inspection revealed that an investigation was not conducted in accordance with the investigational plan, specifically regarding disease progression criteria and inclusion criteria documentation. Additionally, the firm failed to prepare or maintain adequate case histories, including missing test article accountability logs and source documentation for subject deaths.