# FDA 483 - Tim Smith, M.D. - December 10, 2024

Source: https://www.globalkeysolutions.net/records/483/tim-smith-md/7085a235-24db-45d6-ab34-f5790583dd87

> FDA 483 for Tim Smith, M.D. on December 10, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tim Smith, M.D.
- Inspection Date: 2024-12-10
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Tim Smith, M.D., a clinical investigator in Cincinnati, OH, revealed significant deviations from protocol and regulatory requirements. The firm failed to conduct an investigation in accordance with the signed agreement and investigational plan. Specifically, investigational product was not stopped for a subject despite exceeding stopping criteria, and a serious adverse event involving suicidal ideation was not reported.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/kathryn-l-suttling/2d4695ca-5ec3-4658-8f46-101cec4ca41d)

Company: https://www.globalkeysolutions.net/companies/tim-smith-md/dcfd1b78-13c8-4ecd-b9b4-5c69058b64a2

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