Zoll Manufacturing Corp. – FDA EIR, Feb 12, 2018

An FDA inspection of Zoll Manufacturing Corp., a Class III medical device manufacturer in Pittsburgh, PA, was conducted from February 6-12, 2018. The inspection, focusing on the company's LifeVest Wearable Defibrillator, was performed under the regulatory framework for medical device manufacturers, utilizing a Level II QSIT review encompassing management, design, production, process controls, and corrective and preventive actions. While no formal deficiencies were identified and no FDA Form 483 was issued, discussions with management addressed several areas for procedural refinement. These included the need to formally integrate and serialize documentation for Corrective and Preventive Action (CAPA) extension requests within company procedures, and the discontinuation of "Resource Constraints" as a justification for such extensions. Additionally, it was noted that some active LifeVest devices had not received a 2012 design improvement aimed at reducing internal damage susceptibility. Management agreed to implement the necessary procedural updates for CAPA extensions and committed to updating the older devices in the field following their current patient use periods.