# FDA 483 - Edward C. Hsiao, M.D., Ph.D. - June 29, 2021

Source: https://www.globalkeysolutions.net/records/483/edward-c-hsiao-md-phd/5f28dc69-32b9-4ad0-86d0-81c456af9f41

> FDA 483 for Edward C. Hsiao, M.D., Ph.D. on June 29, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Edward C. Hsiao, M.D., Ph.D.
- Inspection Date: 2021-06-29
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Edward C. Hsiao, M.D., Ph.D., a clinical investigator in San Francisco, CA, was inspected by the FDA. The inspection revealed a significant issue with the timely reporting of serious adverse events (SAEs) to the Institutional Review Board (IRB) for two clinical studies. This indicates a failure to adhere to the investigational plan and proper oversight of patient safety reporting.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/dustin-tran/52b41643-a5f9-4b2e-8da4-24beca42b1cd)

Company: https://www.globalkeysolutions.net/companies/edward-c-hsiao-md-phd/7b64fc14-de50-47d4-83d3-8e08e7866ce9

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b