# FDA 483 - Sasidhar P. Kilaru, M.D. - November 23, 2021

Source: https://www.globalkeysolutions.net/records/483/sasidhar-p-kilaru-md/6fb4f910-62c5-455c-bcb4-a50f73ecbc94

> FDA 483 for Sasidhar P. Kilaru, M.D. on November 23, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sasidhar P. Kilaru, M.D.
- Inspection Date: 2021-11-23
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Sasidhar P. Kilaru, M.D., a clinical investigator in Cincinnati, OH, was cited for significant deviations from an investigational plan during an FDA inspection. The inspection revealed multiple instances of non-compliance, including enrolling subjects who met exclusion criteria, treating subjects with incorrect medical devices, and failing to report serious adverse events to the sponsor in a timely manner. These findings indicate a serious lack of adherence to study protocols and regulatory requirements for clinical trials.

## Related Documents

- [EIR - 2021-11-23](https://www.globalkeysolutions.net/records/eir/sasidhar-p-kilaru-md/79745a05-cad7-46c3-8255-3b652e5ac45c)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/yvette-m-lacour-davis/8bae7c3f-2c46-4bf0-9e77-beaa25cdad91)

Company: https://www.globalkeysolutions.net/companies/sasidhar-p-kilaru-md/3434b38e-0774-4c78-8d2e-79f6e88482d5

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