Radhamangalam J. Ramamurthi, M.D. – FDA 483, Sep 20, 2024

Radhamangalam J. Ramamurthi, M.D., a clinical investigator in Stanford, CA, was cited for significant deficiencies in conducting a clinical investigation. Observations included enrolling a subject who met exclusion criteria and had an inadequate informed consent process for another subject's legally authorized representative. Additionally, the firm failed to maintain adequate and accurate case histories, specifically regarding the documentation of protocol deviations in electronic case report forms.