# FDA 483 - Saranya Chumsri MD - September 10, 2020

Source: https://www.globalkeysolutions.net/records/483/saranya-chumsri-md/b031b634-254c-40a2-be42-48431625de46

> FDA 483 for Saranya Chumsri MD on September 10, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Saranya Chumsri MD
- Inspection Date: 2020-09-10
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Saranya Chumsri MD, a Sponsor-Investigator in Jacksonville, FL, revealed a significant failure to adhere to human subject protection protocols. The firm failed to promptly report critical information, specifically findings from a Data Safety Monitoring Committee re-audit and the temporary closure of a clinical study, to the Institutional Review Board (IRB). This oversight led to the IRB suspending subject enrollment for the study, highlighting a serious lapse in regulatory compliance.

## Related Officers

- [Leon L. Crawley](https://www.globalkeysolutions.net/people/leon-l-crawley/973f0ced-69a4-4adb-9e3c-e088e78a4516)

Company: https://www.globalkeysolutions.net/companies/saranya-chumsri-md/56a5399f-45cf-4fe9-8518-90e8f24fe072

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