# FDA 483 - Steven C. Kester, M.D. - May 27, 2022

Source: https://www.globalkeysolutions.net/records/483/steven-c-kester-md/14980489-0670-43ee-ab92-07ee26adcc96

> FDA 483 for Steven C. Kester, M.D. on May 27, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steven C. Kester, M.D.
- Inspection Date: 2022-05-27
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: The FDA inspected Clinical Research Center of Florida & Urology Center of Florida in Pompano Beach, FL, and identified significant deficiencies in their conduct of clinical studies. The firm failed to maintain adequate and accurate case histories, evidenced by missing source documents and numerous time inconsistencies in study records. Additionally, the inspection revealed a failure to obtain proper informed consent from human subjects before performing study-related procedures.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/sheri-l-stephenson/dd4f3755-bb3b-4a14-a08f-8d59fbb0b6fa)

Company: https://www.globalkeysolutions.net/companies/steven-c-kester-md/60b88fd1-7b62-4f85-a516-f926428eaa1b

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