FDA WARNING_LETTER - Abiomed Inc. - April 13, 2023

The FDA issued a Warning Letter to Abiomed, Inc. following a March-April 2023 inspection, citing significant violations for their Impella Pumps and Impella Connect System. The Impella Connect System was deemed adulterated for lacking Premarket Approval (PMA) as its software functions provide patient-specific, time-critical medical information. Multiple Quality System (QS) regulation violations (21 CFR Part 820) were identified. These included failures to identify and prevent recurrence of nonconforming products (21 CFR 820.100(a)(3)), specifically regarding purge sidearm leaks where Health Hazard Evaluations (HHEs) and recall actions were not initiated. The firm also failed to verify or validate corrective and preventive actions (CAPA) for effectiveness (21 CFR 820.100(a)(4)), and to properly evaluate complaints for Medical Device Reporting (MDR) reportability (21 CFR 820.198(a)(3)), resulting in delayed or unsubmitted MDRs. Further violations involved misbranding due to failures in Medical Device Reporting (21 CFR Part 803) and Reports of Corrections and Removals (21 CFR Part 806). Abiomed failed to submit MDRs within 30 days for events involving death or serious injury (21 CFR 803.50(a)(1)), and for malfunctions likely to cause death or serious injury if recurring (21 CFR 803.50(a)(2)). Additionally, corrections or removals to reduce health risks were not reported to the FDA within 10 working days (21 CFR 806.10(b)), including several technical bulletins and product updates. The FDA found the firm's responses inadequate, noting ongoing corrective actions lacked sufficient documentation. Abiomed must promptly address these systemic violations, providing a comprehensive written response within fifteen business days detailing specific steps, documentation, and a timetable. Non-compliance may lead to regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts, PMA approvals, and Certificates to Foreign Governments.