# FDA 483 - H. Henry Li, MD - March 24, 2023

Source: https://www.globalkeysolutions.net/records/483/h-henry-li-md/82bd6f59-094e-46e8-9b5e-c307e92c5d96

> FDA 483 for H. Henry Li, MD on March 24, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: H. Henry Li, MD
- Inspection Date: 2023-03-24
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Huamin Henry Li, M.D., Clinical Investigator, revealed a significant deficiency in obtaining informed consent for pediatric clinical subjects. The investigator failed to consistently secure the required signatures from both parents, despite IRB stipulations. This issue affected all 24 enrolled pediatric subjects in a clinical investigation involving children.

## Related Officers

- [Consumer Safety Officer/BIMO Investigator](https://www.globalkeysolutions.net/people/david-l-chon/227b9c21-14c4-442b-bdc3-ad167567fd92)
- [Lucilla Facchin](https://www.globalkeysolutions.net/people/lucilla-facchin/e5c5c863-b2f4-44a8-8093-d1cb4f71949b)

Company: https://www.globalkeysolutions.net/companies/h-henry-li-md/b4081416-8113-468d-ba0f-ef800f30d2c5

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64