Fernanda P. Silveira, M.D.July 1, 2021

FDA 483 - Fernanda P. Silveira, M.D. - July 01, 2021

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Record Details

An FDA inspection of Fernanda P. Silveira, M.D., a clinical investigator in Pittsburgh, PA, revealed a significant failure to maintain adequate case histories for protocol SHP620-303. Specifically, the site lacked proper documentation for subject dosing of investigator-assigned treatments and exhibited discrepancies in drug accountability for Maribavir, indicating poor record-keeping practices.

Company: Fernanda P. Silveira, M.D.
Inspection Date: July 1, 2021
Product Type: Drugs
Office: Philadelphia District Office
Person: Cynthia L. Rakestraw

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