FDA 483 - Zenflow, Inc. - June 06, 2025

An FDA inspection of Zenflow, Inc. in South San Francisco, CA, identified significant issues related to the conduct of an investigational study. The firm failed to provide investigators with necessary information, ensure proper monitoring, and promptly inform the FDA of significant new information, specifically concerning delayed Serious Adverse Event (SAE) reporting. These findings indicate deficiencies in clinical trial oversight and regulatory reporting practices.