# FDA 483 - Sameek Roychowdhury, MD - January 22, 2021

Source: https://www.globalkeysolutions.net/records/483/sameek-roychowdhury-md/8e9bcf4e-0c6d-4c00-b450-cea63e8a8b9b

> FDA 483 for Sameek Roychowdhury, MD on January 22, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sameek Roychowdhury, MD
- Inspection Date: 2021-01-22
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Sameek Roychowdhury, MD in Columbus, OH, revealed significant deviations from the investigational plan, including the enrollment of ineligible subjects and untimely reporting of serious adverse events. The firm also failed to maintain adequate and accurate case histories, with missing critical information and insufficient documentation for serious adverse event reporting.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/sameek-roychowdhury-md/83ca1e41-4bf5-418e-b31c-91e64600c772

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