# FDA 483 - Dane Technologies - March 18, 2022

Source: https://www.keypedia.com/records/483/dane-technologies/38294e49-cfc9-486a-bd4b-451a25231912

> FDA 483 for Dane Technologies on March 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dane Technologies
- Inspection Date: 2022-03-18
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: This FDA Form 483 was issued to Dane Technologies, a medical device manufacturer in Maple Grove, MN, following an inspection from March 16-18, 2022. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning management review, internal quality audits, and procedures for servicing activities and complaint handling. These observations indicate a lack of adherence to established quality system requirements.

## Related Documents

- [483 - 2025-08-25](https://www.keypedia.com/records/483/dane-technologies/eb2152e1-fdf2-4f3c-8f22-1a749d767003)

## Related Officers

- [Ralph W. Jerndal](https://www.keypedia.com/people/ralph-w-jerndal/f27d4e95-6601-492c-95e4-7638a6f48cc6)

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