483
Fernanda P. Silveira, M.D.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.
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