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

Source: https://www.keypedia.com/records/483/zeller-power-products-llc/5e288f3e-fa01-4874-b027-06644a3c56b9

> FDA 483 for Zeller Power Products, LLC on November 09, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zeller Power Products, LLC
- Inspection Date: 2018-11-09
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2018-11-09](https://www.keypedia.com/records/warning_letter/zeller-power-products-llc/116b5408-154a-4eb3-ba68-1632d407c0e4)
- [483 - 2021-09-24](https://www.keypedia.com/records/483/zeller-power-products-llc/25dc843e-2a93-42df-8a31-18c9feb40968)

## Related Officers

- [James R. Montero](https://www.keypedia.com/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.keypedia.com/companies/zeller-power-products-llc/c74f378e-be0a-4536-b7d7-1d5edf87fd39

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b