# FDA 483 - Clarus Medical, Llc - May 22, 2025

Source: https://www.globalkeysolutions.net/records/483/clarus-medical-llc/ffcd37fd-12d9-4976-a829-9ddd7f784474

> FDA 483 for Clarus Medical, Llc on May 22, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Clarus Medical, Llc
- Inspection Date: 2025-05-22
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Clarus Medical, Llc in Minneapolis, MN, was inspected by the FDA from May 19-22, 2025, resulting in three observations. The inspection revealed significant issues with the firm's quality system, specifically regarding design change procedures, risk analysis, and the control of nonconforming products. These findings indicate a need for improved adherence to regulatory requirements for medical device manufacturing.

## Related Documents

- [483 - 2021-03-10](https://www.globalkeysolutions.net/records/483/clarus-medical-llc/44aae701-999d-488d-8680-c6ab4878d3b5)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/clarus-medical-llc/9b867a63-6f10-4b5b-ac36-42a442d6c3a5

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