FDA 483 - Agile Devices, Inc. - February 20, 2026

Agile Devices, Inc. in Newton Center, MA, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in design control, complaint handling, corrective and preventive actions (CAPA), supplier management, and risk management processes, particularly concerning the Angler Microcatheter. These issues indicate a lack of adequate procedures and adherence to existing ones, potentially impacting device safety and performance.