FDA 483 - Maria Cuesta Torres, M.D. - May 18, 2023

An FDA inspection of Maria Cuesta Torres, M.D., a clinical investigator in Miami Lakes, FL, revealed a significant failure to maintain adequate and accurate case histories. Specifically, the firm lacked source documentation to support inclusion criteria for multiple subjects and failed to document changes made during subsequent evaluations. This indicates a serious deficiency in record-keeping practices for clinical investigations.