# FDA 483 - Dr. James A. Thompson, M.D. - September 27, 2023

Source: https://www.keypedia.com/records/483/dr-james-a-thompson-md/be2fd96d-6e37-4671-9eaa-807641d7964e

> FDA 483 for Dr. James A. Thompson, M.D. on September 27, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. James A. Thompson, M.D.
- Inspection Date: 2023-09-27
- Product Type: other
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Inova Health System, specifically clinical investigator Dr. James Thompson, revealed significant deviations from the investigational plan and study protocol. The inspection identified issues including the enrollment of ineligible subjects, failure to assess and record adverse events, missing required subject records, and the use of unblinded personnel for follow-up calls. These findings indicate a lack of adherence to proper clinical study conduct.

## Related Officers

- [Consumer Safety Officer/BIMO Investigator](https://www.keypedia.com/people/david-l-chon/227b9c21-14c4-442b-bdc3-ad167567fd92)

Company: https://www.keypedia.com/companies/dr-james-a-thompson-md/30b50b2c-ccc0-4e93-bb43-1ded690858a5

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64