FDA 483 - Helen K. Chew, M.D. - March 10, 2021

Helen K. Chew, M.D., a clinical investigator in Sacramento, CA, was cited for significant deficiencies in the conduct of clinical investigations. Observations included failures to follow investigational plans, collect required safety data, report protocol deviations to the IRB, maintain accurate case histories, and promptly report adverse events to the sponsor. Additionally, the firm failed to obtain proper informed consent from a human subject before conducting a study-related test.