# FDA 483 - Collaborative Care Diagnostics, LLC dba BioMedix - October 18, 2021

Source: https://www.keypedia.com/records/483/collaborative-care-diagnostics-llc-dba-biomedix/f97c0474-caad-4bcb-b4f2-d913c27a238c

> FDA 483 for Collaborative Care Diagnostics, LLC dba BioMedix on October 18, 2021. 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: 2021-10-18
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Collaborative Care Diagnostics, LLC dba PCL-Medix in Eagan, MN, revealed two observations concerning inadequate design control procedures for their PADnet 4.0 system. The firm failed to adequately establish and implement procedures for design validation, with specific requirements not being tested. Additionally, procedures for design input were not adequately established, as the product requirement specifications lacked crucial system requirements.

## Related Officers

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

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