FDA 483 - BioEclipse Therapeutics, Inc. - March 25, 2025

An FDA inspection of BioEclipse Therapeutics, Inc. in Mountain View, CA, revealed a significant failure in the proper monitoring of a clinical study. The sponsor did not adequately conduct monitoring activities, including during an enrollment pause, which resulted in numerous unresolved protocol deviations and unmonitored adverse and serious adverse events. This indicates a serious lapse in ensuring study integrity and subject safety.