# FDA 483 - Madeleine Duvic, M.D. - January 13, 2023

Source: https://www.globalkeysolutions.net/records/483/madeleine-duvic-md/9a9d50ce-a017-4d6e-b868-c2e5b05a4d64

> FDA 483 for Madeleine Duvic, M.D. on January 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Madeleine Duvic, M.D.
- Inspection Date: 2023-01-13
- Product Type: drugs
- Office Name: Division of Southwest Imports
- Summary: An FDA inspection of Madeleine Duvic, M.D., a clinical investigator in Houston, revealed significant deficiencies in the conduct of Study E7777-G000-302. Observations included a failure to timely report a serious adverse event to the sponsor, obtaining informed consent from a non-English speaking subject using an English document, and inadequate maintenance of dosing records. These issues indicate a lack of adherence to investigational plan requirements and informed consent regulations.

## Related Officers

- [Debra L. Boyd-Seale](https://www.globalkeysolutions.net/people/debra-l-boyd-seale/6f9af6f9-8deb-494d-b73e-fca63b95d7d2)

Company: https://www.globalkeysolutions.net/companies/madeleine-duvic-md/47d725b5-78ef-4988-a83c-52b48e3f8c47

Office: https://www.globalkeysolutions.net/offices/division-of-southwest-imports/1a990c0f-8880-49cd-9fdf-e7e450072e5a