# FDA 483 - Hans C. Lee, M.D. - January 10, 2020

Source: https://www.keypedia.com/records/483/hans-c-lee-md/f8c6dfc9-24b6-4cf2-b8da-761e426f4c69

> FDA 483 for Hans C. Lee, M.D. on January 10, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hans C. Lee, M.D.
- Inspection Date: 2020-01-10
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Hans Lee, M.D., a clinical investigator in Houston, TX, revealed a significant deviation from the investigational plan. The firm failed to properly conduct an investigation, specifically regarding the incorrect dosing of multiple subjects in a study. This resulted in at least 7 out of 15 subjects receiving improper study drug dosages, contrary to the protocol's requirements for holding or reducing the drug.

## Related Officers

- [CSO](https://www.keypedia.com/people/andrea-a-branche/9ffe9b53-7963-49a6-be4e-25e644f1759f)

Company: https://www.keypedia.com/companies/hans-c-lee-md/7280a127-79bb-4842-acd5-2e1ac3f7ef7a

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9