# FDA 483 - Ashley L. Devonshire, M.D., MPH - November 20, 2025

Source: https://www.globalkeysolutions.net/records/483/ashley-l-devonshire-md-mph/66bbd384-3a36-40fa-8301-d9866283f0e9

> FDA 483 for Ashley L. Devonshire, M.D., MPH on November 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ashley L. Devonshire, M.D., MPH
- Inspection Date: 2025-11-20
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Cincinnati Children's Hospital Medical Center (CCHMC) identified two significant observations related to a clinical investigation. The inspection revealed failures in maintaining adequate case histories, specifically regarding the documentation of serum sample processing steps. Additionally, an investigation was not conducted in accordance with the established investigational plan, as evidenced by deviations in serum sample centrifugation times.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/ashley-l-devonshire-md-mph/79c50fa2-35f5-4a85-9dba-71896d93c46c

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