# FDA 483 - Collaborative Care Diagnostics, LLC dba BioMedix - February 09, 2026

Source: https://www.keypedia.com/records/483/collaborative-care-diagnostics-llc-dba-biomedix/2cdfb5d3-a722-4cb4-9def-3e1c847c282b

> FDA 483 for Collaborative Care Diagnostics, LLC dba BioMedix on February 09, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Collaborative Care Diagnostics, LLC dba BioMedix
- Inspection Date: 2026-02-09
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Collaborative Care Diagnostics, LLC. in Eagan, MN, revealed significant deficiencies in their quality system for medical device manufacturing. The firm failed to adequately document risk management processes, evaluate design changes, and ensure proper Unique Device Identifier (UDI) labeling and database submission for their PADnet 4.0 and PADnet Xpress products. These observations indicate a lack of robust controls over product realization and regulatory compliance.

## Related Documents

- [483 - 2021-10-18](https://www.keypedia.com/records/483/collaborative-care-diagnostics-llc-dba-biomedix/f97c0474-caad-4bcb-b4f2-d913c27a238c)

## Related Officers

- [investigator](https://www.keypedia.com/people/tyler-r-courtney/08ea96c4-cd5a-4793-b7e4-fb2b9ee2b9ef)

Company: https://www.keypedia.com/companies/collaborative-care-diagnostics-llc-dba-biomedix/70de2368-51b6-488d-a1a4-44deffe74cb3

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