BioEclipse Therapeutics, Inc.March 25, 2025

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

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Record Details

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.

Company: BioEclipse Therapeutics, Inc.
Inspection Date: March 25, 2025
Product Type: Other
Office: Division of Human and Animal Food Operations - West V
People: Kristin M. Abaonza
Joan T. Briones (Supervisory Consumer Safety Officer)

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ID · 15a9d628-2d6b-4389-b51e-8419da94fe40