# FDA 483 - Sagar Sardesai, M.D. - February 12, 2021

Source: https://www.keypedia.com/records/483/sagar-sardesai-md/f9d36c46-575a-4013-811f-f6de71041a70

> FDA 483 for Sagar Sardesai, M.D. on February 12, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sagar Sardesai, M.D.
- Inspection Date: 2021-02-12
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: The FDA inspected Sagar Sardesai, M.D. at the Ohio State Comprehensive Cancer Center, James Cancer Hospital in Columbus, OH, from February 5-12, 2021. The inspection revealed a significant issue regarding the failure to promptly report serious adverse events to the sponsor, as required by protocol specifications for investigational drugs. This indicates a lapse in critical safety reporting procedures during clinical trials.

## Related Officers

- [investigator](https://www.keypedia.com/people/geoffrey-k-kilili/b00aeedf-95bd-4ccf-a23e-6e12e60249c4)

Company: https://www.keypedia.com/companies/sagar-sardesai-md/48fb6003-8be0-4ab0-bb9b-61893e4ca3e5

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22