# FDA 483 - Bankole Johnson MD - October 28, 2020

Source: https://www.globalkeysolutions.net/records/483/bankole-johnson-md/b1e53100-acd1-4fbe-b531-c44488a5c067

> FDA 483 for Bankole Johnson MD on October 28, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bankole Johnson MD
- Inspection Date: 2020-10-28
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of James William Woodlee, Partner Kleinfeld, Kaplan, & Becker, LLP, a clinical investigator in Charlottesville, VA, revealed significant deficiencies in clinical trial conduct. Observations included inadequate drug disposition records, numerous protocol deviations in subject management and data collection, failures in IRB continuing review submissions, and lack of required financial disclosure statements. These issues indicate a serious lack of oversight and adherence to regulatory requirements in clinical investigations.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephanie-c-mangigian/0cf25e6b-1e5d-4088-a13c-11483e2380ba)

Company: https://www.globalkeysolutions.net/companies/bankole-johnson-md/ca0b1ff8-ef95-48b3-bf55-a05dd5fe12ee

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