# FDA 483 - Dane Technologies - August 25, 2025

Source: https://www.keypedia.com/records/483/dane-technologies/eb2152e1-fdf2-4f3c-8f22-1a749d767003

> FDA 483 for Dane Technologies on August 25, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dane Technologies
- Inspection Date: 2025-08-25
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Dane Technologies in Maple Grove, MN, a manufacturer of the Wheel Chair Mover device, revealed significant deficiencies in its quality system. The firm failed to adequately establish corrective and preventive action procedures, servicing procedures, and did not conduct management reviews or quality audits with sufficient frequency. These issues indicate a systemic breakdown in maintaining an effective quality management system.

## Related Documents

- [483 - 2022-03-18](https://www.keypedia.com/records/483/dane-technologies/38294e49-cfc9-486a-bd4b-451a25231912)

## Related Officers

- [Albert L. Nguyen](https://www.keypedia.com/people/albert-l-nguyen/496338d0-71c4-43da-92f0-09515559d9fc)

Company: https://www.keypedia.com/companies/dane-technologies/81329829-4d98-4bcd-9a9f-bea75d18592e

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