FDA 483 - Rapa Therapeutics LLC - June 02, 2025
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Rapa Therapeutics LLC, a sponsor in Rockville, MD, was cited for significant deficiencies in the monitoring of a clinical study during an FDA inspection from May 27 to June 2, 2025. The firm failed to implement proper monitoring plans and SOPs, perform source data verification, identify root causes for protocol deviations, and ensure timely submission of data safety monitoring board reports to the Institutional Review Board. These issues indicate a lack of adequate oversight in conducting the study according to protocol and Good Clinical Practice guidelines.
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