# FDA 483 - Banji Awosika, M.D. - January 27, 2023

Source: https://www.globalkeysolutions.net/records/483/banji-awosika-md/69089dd8-30f8-4e12-b5fc-f457e60c1807

> FDA 483 for Banji Awosika, M.D. on January 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Banji Awosika, M.D.
- Inspection Date: 2023-01-27
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Banji Awosika, M.D. in Orlando, FL, a clinical investigator, revealed significant deviations from the investigational plan. The firm failed to ensure subjects were dosed only after complete safety lab review and did not properly document adjusted glomerular filtration rate (aGFR) calculations. These failures led to the enrollment of subjects who did not meet study entry criteria.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/gene-r-gunn/3c011052-9264-461e-a92e-4af3cc26819c)

Company: https://www.globalkeysolutions.net/companies/banji-awosika-md/44db71ec-f2ad-41ca-a8dd-347f615a3453

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6