# FDA 483 - Joseph C Gathe, Jr, MD, CI - March 10, 2023

Source: https://www.globalkeysolutions.net/records/483/joseph-c-gathe-jr-md-ci/2141ea23-7852-49e8-bd3e-0284f5c43ca6

> FDA 483 for Joseph C Gathe, Jr, MD, CI on March 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Joseph C Gathe, Jr, MD, CI
- Inspection Date: 2023-03-10
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Joseph C Gathe, Jr, MD, CI, a clinical investigator in Houston, revealed significant deficiencies in the conduct of a clinical study. The investigator failed to follow the study protocol, specifically regarding adverse event reporting and the documentation of subject inclusion/exclusion criteria. These issues indicate a lack of adherence to investigational plan requirements.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/joseph-c-gathe-jr-md-ci/4ea3d3ec-d339-4ee0-820f-abc8bacffc17

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab