FDA 483 - Leila Chaychi, M.D. - October 22, 2021

An FDA inspection of Leila Chaychi, M.D., a clinical investigator in San Carlos, CA, revealed significant deficiencies in the conduct of clinical investigations. Observations included failures to adhere to investigational plans, enroll eligible subjects, and properly document informed consent. These issues indicate a lack of control over study conduct and subject protection.