
FDA Issues Warning Letter to JNJ Subsidiary Abiomed Citing Issues with Impella Heart Pump
The FDA has issued a warning letter to Johnson & Johnson (JNJ) subsidiary Abiomed following a recent inspection conducted by the United States Food and Drug Administration (FDA) from March 1, 2023, through April 13, 2023. During the inspection, significant concerns were raised about the operations of the company, which produces class III devices known as Impella Pumps, that are vital in providing temporary ventricular support in critical care settings.
During the inspection, the FDA determined that the Impella Connect System, a software and hardware solution that works in tandem with the Impella Pumps, was adulterated. This determination was based on the system’s intended use and its ability to provide vital medical information and notifications in critical care settings. The Impella Connect System comprises a web-based user portal and a remote link module designed to monitor and manage Impella Pumps. This system allows remote monitoring and provides case-specific medical information, generating time-critical alarms to notify healthcare providers. The FDA notified Abiomed that this function classifies the system as a medical device and necessitates premarket authorization.
The FDA inspection further revealed several violations under the current good manufacturing practice requirements of the Quality System regulation pertaining to device incidents and documentation. These violations included that the firm failed to conduct health hazard evaluations and issue formal recall actions based on the risk to health in response to nonconformities and that recommendations resulting from incident investigations were not consistently implemented, leading to noncompliance. The FDA also accused Abiomed of failure to submit reports to the FDA within 30 calendar days of becoming aware of information suggesting that an Impella Pump may have caused or contributed to a patient’s death or a serious injury. Additionally, the FDA claimed Abiomed failed to report several complaints which suggested malfunctions of the Impella 5.5 with SmartAssist system to the FDA within the required timeframe.
Abiomed’s responses to the FDA which were dated May 3, 2023, June 19, 2023, August 3, 2023, and September 8, 2023, were deemed inadequate by the FDA. The firm claimed that the Impella Connect System was non-device clinical decision support software, and thus exempt from FDA regulation. However, the FDA disagreed, asserting that the system’s functions, such as time-critical alarms and patient-specific medical information, fell under the device category, mandating premarket authorization. The FDA also believed that Abiomed’s response to the quality concerns were inadequate. The FDA noted that Abiomed claimed to have initiated corrective actions, such as investigating the root causes of late reporting and conducting a retrospective review of complaints. However, the documentation or evidence of completed corrective actions was not provided for all corrective actions, and many actions were still ongoing.
The FDA’s Warning Letter signals a significant regulatory compliance issue for Abiomed. Failure to address these concerns by the company may lead to significant regulatory actions, including seizure, injunction, and civil money penalties. Failure to comply may also delay approvals for new medical devices. Johnson & Johnson has not issued a statement pertaining to the warning letter.