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

An FDA inspection of Abiomed, Inc., conducted from May 28, 2025, to August 5, 2025, identified several significant deficiencies in their quality system. The observations, many of which were repeat findings from a previous inspection, highlight a lack of adherence to established regulatory requirements for medical device manufacturers. A primary concern was the inadequacy of the company's corrective and preventive action (CAPA) procedures. Abiomed failed to consistently evaluate product design changes during investigations for critical issues with their Impella System, including problems leading to Class I and Class II recalls related to device interactions and biomaterial ingestion. Additionally, complaints were not adequately integrated into ongoing CAPA investigations. The inspection also cited Abiomed for failing to report a significant design modification to the Automated Impella Controller (AIC) consoles to the FDA. This change was implemented to mitigate a risk of unit failures due to cracks. Furthermore, the firm failed to submit 510 Medical Device Reports (MDRs), including 142 reports involving patient deaths, within the required 30-day timeframe. Lastly, several critical quality procedures, such as those for complaint handling and design control, were found not to have been properly approved by designated personnel before being issued. Abiomed has acknowledged these observations, promising to implement corrective actions for the CAPA, reporting, and MDR deficiencies, and has reportedly corrected the document approval issues. These actions are essential to ensure the company's compliance with quality system regulations and the safety of its medical devices.