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

Source: https://www.keypedia.com/records/warning_letter/zeller-power-products-llc/116b5408-154a-4eb3-ba68-1632d407c0e4

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

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## Details

- Record Type: WARNING_LETTER
- Company Name: Zeller Power Products, LLC
- Inspection Date: 2018-11-09
- Product Type: Devices
- Office Name: Division of Medical Device and Radiological Health Operations East
- Summary: The FDA issued a Warning Letter to Zeller Power Products, LLC, following a November 6-9, 2018 inspection of their Las Vegas, NV facility. The firm manufactures Class III Automated External Defibrillator (AED) Batteries, which are considered adulterated due to non-conformity with Quality System Regulation (21 CFR Part 820) and misbranded under sections 502(c) and 502(t)(2) of the Federal Food, Drug, and Cosmetic Act.

Key violations include:
1. **Failure to validate design (21 CFR 820.30(g))**: No documentation for battery shelf-life, operational guarantee, or shock capacity. Software for battery compatibility with defibrillators was also not validated. This is a repeat observation.
2. **Failure to establish design control procedures (21 CFR 820.30(a))**: No documented procedures for design plan, inputs, validation, reviews, or risk analysis. This is a repeat observation.
3. **Failure to establish complaint handling procedures (21 CFR 820.198(a))**: No formal procedures for receiving, reviewing, or evaluating complaints, including MDR reporting. Returned Goods Authorizations (RGAs) were not documented as complaints. This is a repeat observation.
4. **Failure to establish acceptance activity procedures (21 CFR 820.

## Related Documents

- [483 - 2018-11-09](https://www.keypedia.com/records/483/zeller-power-products-llc/5e288f3e-fa01-4874-b027-06644a3c56b9)
- [483 - 2021-09-24](https://www.keypedia.com/records/483/zeller-power-products-llc/25dc843e-2a93-42df-8a31-18c9feb40968)

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/shari-j-shambaugh/aaea1185-eca8-41f8-bec7-d5d0024b582d)
- [Bram D. Zuckerman](https://www.keypedia.com/people/bram-d-zuckerman/f1db0188-ca91-4c3a-828d-f3c6f7450e54)

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

Office: https://www.keypedia.com/offices/division-of-medical-device-and-radiological-health-operations-east/360ecccc-5273-4159-86e7-9eaeb8d41456