# FDA 483 - James L. Bicksel MD - October 08, 2020

Source: https://www.globalkeysolutions.net/records/483/james-l-bicksel-md/c49db0c2-5e03-4e66-a417-933fc0c72f6f

> FDA 483 for James L. Bicksel MD on October 08, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: James L. Bicksel MD
- Inspection Date: 2020-10-08
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: James L. Bicksel MD, a clinical investigator in Fairfax, VA, was cited for significant deficiencies in conducting clinical investigations. Observations included failing to follow the investigational plan by enrolling an excluded subject and missing required MRI scans, inadequate investigational drug disposition records, and a failure to maintain accurate and complete case histories, including informed consent forms and follow-up documentation for adverse events. These issues indicate a serious lack of adherence to clinical trial protocols and record-keeping standards.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/young-m-yoon/fe5ad575-57d1-4329-9e4b-a997ed79499c)

Company: https://www.globalkeysolutions.net/companies/james-l-bicksel-md/3d8d1663-5b44-480d-94f3-4a0558238825

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