# FDA 483 - Shaila U. Gogate, M.D. - April 24, 2025

Source: https://www.keypedia.com/records/483/shaila-u-gogate-md/0b742ae3-01e5-4347-983b-2a051944c8eb

> FDA 483 for Shaila U. Gogate, M.D. on April 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shaila U. Gogate, M.D.
- Inspection Date: 2025-04-24
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Shaila U. Gogate, M.D. in Denver, CO, revealed significant deficiencies in the conduct of a clinical investigation. Observations included failures in subject eligibility screening, inadequate review of adverse events, and issues with informed consent and maintaining accurate case histories. These findings indicate a lack of adherence to study protocols and regulatory requirements, potentially impacting data integrity and subject safety.

## Related Officers

- [Theressa B. Smith](https://www.keypedia.com/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.keypedia.com/companies/shaila-u-gogate-md/9431ab7a-4440-4f9d-b3a3-bdb60031833f

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face