# Electromed, Inc. – FDA 483, Feb 12, 2026

Source: https://www.keypedia.com/records/483/electromed-inc/f6eb8a26-4a65-45f9-a57b-55f65495fb9b

> FDA 483 for Electromed, Inc. on February 12, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Electromed, Inc.
- Inspection Date: 2026-02-12
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Electromed, Inc. in New Prague, MN, a medical device manufacturer, revealed two significant observations. The firm's procedures for controlling nonconforming product were found to be inadequately documented, specifically lacking processes for investigation and recording results. Additionally, the receiving inspection process for critical components was not adequately implemented, failing to follow established sampling plans.

## Related Documents

- [483 - 2023-01-13](https://www.keypedia.com/records/483/electromed-inc/19f827b6-7dac-4558-b764-3930fa8df658) — date: January 13, 2023

## Related Officers

- [Investigator ](https://www.keypedia.com/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.keypedia.com/companies/electromed-inc/2e0611e6-8d86-449f-92c2-322112b6169a

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d