# FDA 483 - Jorge T. Caso, M.D. - November 04, 2024

Source: https://www.keypedia.com/records/483/jorge-t-caso-md/16c52d7a-8eab-4793-abad-6806d88d6a9f

> FDA 483 for Jorge T. Caso, M.D. on November 04, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jorge T. Caso, M.D.
- Inspection Date: 2024-11-04
- Product Type: drugs
- Office Name: Florida District Office
- Summary: An FDA inspection of Suncoast Research Associates, LLC. dba SRA Trials, LLC. in Miami, FL, revealed significant issues with data integrity. The firm failed to accurately prepare and maintain case histories, with numerous discrepancies between paper source records and electronic case report forms for multiple subjects across two different protocols. This indicates a serious breakdown in the reliability of study data.

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Company: https://www.keypedia.com/companies/jorge-t-caso-md/d3d32c1f-71d1-47b5-bf60-156e202a43cd

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9