# FDA 483 - Mark Fleming, MD - May 03, 2017

Source: https://www.keypedia.com/records/483/mark-fleming-md/52640b50-3f49-4547-931a-ae42a1c87ac1

> FDA 483 for Mark Fleming, MD on May 03, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mark Fleming, MD
- Inspection Date: 2017-05-03
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA Form 483 was issued to Mark Fleming, MD, a clinical investigator in Norfolk, VA, following an inspection from April 26 to May 3, 2017. The inspection revealed a significant deviation from an investigational plan. Specifically, a study subject with elevated liver enzymes was not discontinued from the study as required by the protocol, and was subsequently dosed with the study drug.

## Related Officers

- [Wilfred A. Darang](https://www.keypedia.com/people/wilfred-a-darang/f0f1e653-891d-47d6-82e3-5ce40a5d3635)

Company: https://www.keypedia.com/companies/mark-fleming-md/4cfb18d3-7852-41d6-a5f0-53f6f684fe33

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e