Latest Fda Inspections News

Antaria has disclosed several FDA-identified GMP compliance issues but assures no impact on product quality or supply, committing to expert-led remediation and enhanced training.

EBR Systems has announced a rescheduling of the FDA Pre-Approval Inspection for its wireless cardiac pacing device to January 14, 2025, while maintaining its regulatory approval timeline for Q1 2025 and a commercial launch later in the year.

EBR Systems Inc. has responded to ASX's price query, denying any undisclosed information behind recent trading spikes and confirming compliance with listing rules. The company also flagged an upcoming FDA inspection announcement.