FDA 483 - Zeller Power Products, LLC - November 09, 2018

Keller Power Products, LLC in Las Vegas, NV, a medical device specification developer, was cited with 11 observations during an FDA inspection from November 6-9, 2018. The inspection revealed significant deficiencies across its quality system, including a lack of established procedures for design control, MDR reporting, complaint handling, supplier evaluation, acceptance activities, design change, CAPA, labeling, quality audits, and management review. Several observations were repeats from a previous inspection, indicating a systemic failure to implement and maintain a compliant quality system for their Automated External Defibrillator Battery.