483
Kadmon Corporation, LLCFDA 483 - Kadmon Corporation, LLC - December 08, 2020
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Record Details
Kadmon Corporation, LLC, a sponsor, was inspected in Cambridge, MA, from December 3-8, 2020. The inspection revealed a significant failure to promptly address a non-compliant clinical investigator in a Phase 2 clinical trial. This led to numerous issues including data integrity problems, patient safety concerns, and inadequate oversight of study conduct.
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