# FDA 483 - Garth O. Vaz, M.D. - February 01, 2019

Source: https://www.globalkeysolutions.net/records/483/garth-o-vaz-md/0a5351ea-9ba2-46dd-89e5-790ba63ef003

> FDA 483 for Garth O. Vaz, M.D. on February 01, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Garth O. Vaz, M.D.
- Inspection Date: 2019-02-01
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: JVC Clinical Research, a clinical investigator site in Gonzales, TX, was inspected regarding two clinical investigations. The inspection revealed a significant failure to adhere to investigational plans, specifically concerning the (b) (4) dosing and dose adjustment algorithms for study subjects. Furthermore, the Principal Investigator did not document the clinical circumstances when deviating from the established dosing protocols.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/leighton-k-ngai/39fc01c8-e40a-45d4-910a-068955d16a06)

Company: https://www.globalkeysolutions.net/companies/garth-o-vaz-md/79e1ba5e-401d-47ae-9154-8d35074e80ea

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