FDA 483 - Amrut Ambardekar, M.D. - December 13, 2024

This FDA Form 483 report details significant deficiencies at Amrut Ambardekar, M.D., a clinical investigator in Aurora, CO. The inspection revealed failures in conducting investigations according to the signed statement of investigator, including incorrect dosing of subjects. Furthermore, the firm failed to promptly report serious adverse events to the sponsor and did not maintain adequate case histories by omitting multiple adverse events for several study subjects.