# FDA 483 - Advanced Research Medical, LLC - December 20, 2022

Source: https://www.globalkeysolutions.net/records/483/advanced-research-medical-llc/021c1a01-2800-4432-aba3-65fb16ad98df

> FDA 483 for Advanced Research Medical, LLC on December 20, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Research Medical, LLC
- Inspection Date: 2022-12-20
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Advanced Research Medical, LLC, a medical device manufacturer in Burnsville, MN, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate corrective and preventive actions, unvalidated manufacturing and cleaning processes, deficient risk analysis, and a failure to submit a required Medical Device Report. The findings indicate a systemic breakdown in quality management and oversight.

## Related Documents

- [483 - 2025-10-01](https://www.globalkeysolutions.net/records/483/advanced-research-medical-llc/662bd757-3cca-41b4-890f-20b1106be712)

## Related Officers

- [Benjamin W. Anderson](https://www.globalkeysolutions.net/people/benjamin-w-anderson/a3c0961c-6a83-4bd7-abb8-02c5c8dd3a35)

Company: https://www.globalkeysolutions.net/companies/advanced-research-medical-llc/f2e3404b-a80d-49bc-a960-9748743dc795

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