FDA 483 - Abiomed, Inc. - April 13, 2023

Abiomed, Inc. in Danvers, MA, was inspected and found to have significant deficiencies in its quality system for medical devices. The firm failed to report corrections and removals to the FDA in a timely manner and demonstrated inadequate procedures for corrective and preventive actions, incident investigations, and complaint handling. These issues led to numerous failures in conducting health hazard evaluations, initiating formal CAPA actions, and submitting required Medical Device Reports (MDRs) for device malfunctions, serious injuries, and patient deaths.