FDA 483 - JenaValve Technology, Inc. - October 10, 2025

An FDA inspection of JenaValve Technology, Inc., a sponsor of an investigational study, revealed significant issues with clinical trial oversight. The firm failed to ensure proper monitoring and provide investigators with necessary information, leading to numerous late reports of Serious Adverse Events and patient deaths across multiple clinical sites. Additionally, the firm lacked documentation of retraining for clinical sites on required reporting timelines.