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

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.