# FDA 483 - Sohan L. Dua, M.D - September 21, 2023

Source: https://www.keypedia.com/records/483/sohan-l-dua-md/c871bb55-63f7-4fd2-902f-448c31cc7883

> FDA 483 for Sohan L. Dua, M.D on September 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sohan L. Dua, M.D
- Inspection Date: 2023-09-21
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Sohan L. Dua, M.D. in Northridge, CA, a clinical investigator for the TRAVERSE study, revealed significant deficiencies in clinical trial conduct. Observations included the failure to promptly report serious adverse events, including a subject's death, to the study sponsor. Additionally, the firm failed to report unanticipated problems involving risk to human subjects to the Institutional Review Board and did not consistently obtain proper informed consent from subjects.

## Related Officers

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Company: https://www.keypedia.com/companies/sohan-l-dua-md/24a62291-2dfe-41ab-805a-0efd7b50ec29

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6