# FDA 483 - Dean L. Harris - May 05, 2023

Source: https://www.globalkeysolutions.net/records/483/dean-l-harris/73b513d9-0f9b-4192-9d7c-2b5eb44cf370

> FDA 483 for Dean L. Harris on May 05, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Dean L. Harris
- Inspection Date: 2023-05-05
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: Dean L. Harris, a clinical investigator in Christchurch, New Zealand, was cited for failing to conduct a study according to the investigational plan. The inspection revealed that subjects continued to receive investigational product past their complete response status, and adverse event causality assessments were not performed according to the protocol's defined codes. These issues indicate significant deviations from the study protocol and a lack of proper oversight.

## Related Officers

- [Bioresearch Monitoring Foreign Inspection Cadre Member](https://www.globalkeysolutions.net/people/richard-w-berning/4637e321-8803-4fcf-911f-bbc810c3487d)

Company: https://www.globalkeysolutions.net/companies/dean-l-harris/93aade9d-4f07-49d1-926d-81ae6e2eb48f

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4