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Abiomed Inc. was cited for manufacturing the Impella Pump devices and the Impella Connect System without proper regulatory authorization, with the latter found to be adulterated under federal law for lacking an approved premarket approval (PMA) application or investigational device exemption. The FDA inspection conducted from March through April 2023 at the company's Danvers, Massachusetts facility identified multiple compliance failures related to Current Good Manufacturing Practice (CGMP) and Quality System Regulation (QSR) requirements, which the company subsequently responded to across four separate submissions. The Impella Connect System, comprising web-based software and hardware components designed to work with the Automated Impella Controller, was specifically flagged as a device marketed without required FDA approval.