483
Asim Roy, M.D.FDA 483 - Asim Roy, M.D. - March 14, 2025
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An FDA inspection of Ohio Sleep Medicine And Neuroscience Institute in Dublin, OH, identified issues with investigational drug disposition records. The firm failed to maintain adequate and organized investigational product accountability records, leading to confusion regarding dispensing dates, quantities, and subject use. This indicates a significant concern regarding data integrity and record-keeping practices for clinical trials.
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