# FDA 483 - Zeller Power Products, LLC - September 24, 2021

Source: https://www.keypedia.com/records/483/zeller-power-products-llc/25dc843e-2a93-42df-8a31-18c9feb40968

> FDA 483 for Zeller Power Products, LLC on September 24, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zeller Power Products, LLC
- Inspection Date: 2021-09-24
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Zeller Power Products, LLC in Wallace, ID, a specification developer for medical devices, received 11 observations during an FDA inspection from September 20-24, 2021. The firm demonstrated systemic failures in establishing and maintaining fundamental quality system procedures, including design control, MDR reporting, complaint handling, and CAPA. Many of these issues were repeat observations from a previous inspection in 2018, indicating a persistent lack of compliance.

## Related Documents

- [483 - 2018-11-09](https://www.keypedia.com/records/483/zeller-power-products-llc/5e288f3e-fa01-4874-b027-06644a3c56b9)
- [WARNING_LETTER - 2018-11-09](https://www.keypedia.com/records/warning_letter/zeller-power-products-llc/116b5408-154a-4eb3-ba68-1632d407c0e4)

## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6