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

An FDA inspection of BioEclipse Therapeutics, Inc. in Mountain View, CA, identified a significant failure in the firm's role as a sponsor to adequately monitor a clinical study. The firm paused enrollment and instructed monitors to cease activities, resulting in unmonitored subjects, numerous unresolved protocol deviations, and unverified serious adverse events. This indicates a severe lapse in ensuring study integrity and patient safety.