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# QS Violations at Zeller Power Products
- URL: https://www.fdaweb.com/qs-violations-at-zeller-power-products/
- Published: 2019-05-21T12:00:00.000Z
- Updated: 2026-09-15T01:28:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144152

An 11/6-11/9/18 FDA inspection at Zeller Power Products’ medical device operations in Las Vegas, NV, found Quality System Regulation and other violations in the firm’s manufacturing of Class 3 automated external defibrillator batteries intended to replace the original equipment manufacturer battery used in Cardiac Science PowerHeart AED G3 automated external defibrillators. A 5/9 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zeller-power-products-llc-570909-05092019?ref=fdaweb.com) says specific violations were: 

- failing to validate the design;
- failing to establish procedures for design control;
- failing to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failing to establish procedures for acceptance activities;
- failing to establish procedures to control product that does not conform to specified requirements;
- failing to establish procedures for corrective and preventive action;
- failing to ensure that the label of every medical device bears a unique device identifier; and
- failing to provide required information to the Global Unique Device Identification Database.

The letter also questions Zeller’s registration and listing status for the Las Vegas office and for the office in Wallace, ID.

Zeller was told to take prompt action to correct the violations addressed in the letter and to respond with a list of specific steps taken to correct the violations and prevent those or similar violations from occurring again, with documentation of each step and a timetable for completion.