FDA 483 - Abiomed, Inc. - August 05, 2025

Abiomed, Inc. in Danvers, MA, was inspected and received a Form FDA 483 with four observations, many of which were repeat findings. The inspection revealed significant issues with the firm's corrective and preventive action procedures, including failure to consider design changes during CAPA investigations and inadequate complaint evaluations. Additionally, the firm failed to report a device correction to the FDA, did not submit numerous Medical Device Reports (MDRs) within the required timeframe, and lacked evidence of proper approval for critical quality procedures.