# FDA 483 - Roberto Salvatori, M.D. - May 13, 2021

Source: https://www.keypedia.com/records/483/roberto-salvatori-md/1eb23203-6235-4a3b-91e4-776c9e840c4f

> FDA 483 for Roberto Salvatori, M.D. on May 13, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Roberto Salvatori, M.D.
- Inspection Date: 2021-05-13
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Roberto Salvatori, M.D. in Baltimore, MD, revealed significant deficiencies in maintaining accurate case histories for clinical investigations. The firm failed to report adverse events and concomitant medications in electronic data capture for multiple studies. These findings indicate serious issues with data integrity and record-keeping practices during clinical trials.

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- [investigator](https://www.keypedia.com/people/john-dan/8a8c42e4-66ec-438d-868e-f32461f9026c)
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Company: https://www.keypedia.com/companies/roberto-salvatori-md/e110006f-2016-497b-acdb-20ba5f665a9b

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e