FDA issues a warning letter for Abiomed Inc. for the reason of “Our inspection also revealed the Impella Connect System device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g).” In addition, “On 10/13/22 an incident investigation was initiated for a software systemic issue/bug involving (b)(4) lots of Impella CP where a software counter that is supposed to reset after a test is complete was not resetting, until the next software application closure/reboot. “The bug in the software responsible for amending new report data carried over from the previous test has been identified and corrected in the source code.” However, your firm failed to validate your corrective action (which involved a software bug fix implemented in AFQ version (b)(4) software code base from previous software AFQ version (b)(4), which could impact the intended use of the device) to ensure that such action was effective.”
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