Maria Cuesta Torres, M.D.May 18, 2023

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

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Record Details

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.

Company: Maria Cuesta Torres, M.D.
Inspection Date: May 18, 2023
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
Person: Emily A. Baldwin (investigator)

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ID · 1ad88d2c-8141-44d2-8be9-a9e8eb64076b