FDA 483 - Rachel A. Kuperman, M.D. - June 27, 2022

An FDA inspection of Rachel A. Kuperman, M.D., a clinical investigator in Paramount, CA, revealed significant deficiencies in the conduct of clinical investigations. Observations included failures to follow the investigational plan, inadequate investigational drug disposition records, and a lack of legally effective informed consent for subjects. These findings indicate serious non-compliance with regulatory requirements for clinical trials.