# FDA 483 - Johnnie M. Woodson, MD - February 02, 2022

Source: https://www.globalkeysolutions.net/records/483/johnnie-m-woodson-md/64800ef4-c142-4509-8785-ab9fc2a35a07

> FDA 483 for Johnnie M. Woodson, MD on February 02, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Johnnie M. Woodson, MD
- Inspection Date: 2022-02-02
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Johnnie M. Woodson, MD, a clinical investigator in Henderson, NV, revealed significant deviations from a clinical investigation protocol. The investigation was not conducted in accordance with the signed statement of investigator, with issues including improper subject enrollment, incomplete follow-up visits, incorrect vital sign measurement procedures, unadministered investigational product, and delayed shipping of blood samples. These findings indicate a serious lack of adherence to the study protocol and regulatory requirements for clinical trials.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/rebecca-t-davis/a821f7ef-0c73-4be1-9a9b-3fc2c07f88c1)

Company: https://www.globalkeysolutions.net/companies/johnnie-m-woodson-md/74dec455-8530-4460-8021-f1e191a8f29a

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b