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

Source: https://www.keypedia.com/records/483/fernanda-p-silveira-md/3c2da0e0-8b2f-4dae-b2b2-fbbdaa4ae56b

> FDA 483 for Fernanda P. Silveira, M.D. on July 01, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fernanda P. Silveira, M.D.
- Inspection Date: 2021-07-01
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: 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.

## Related Officers

- [Cynthia L. Rakestraw](https://www.keypedia.com/people/cynthia-l-rakestraw/ca138abf-e5d4-43ca-b9d2-79ea6294a8c8)

Company: https://www.keypedia.com/companies/fernanda-p-silveira-md/865576da-a018-4e6a-a394-fcca0d8af72d

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8