# FDA 483 - OnePacs, LLC - December 02, 2025

Source: https://www.keypedia.com/records/483/onepacs-llc/7c29b998-4f93-4a15-9e59-157aff56864b

> FDA 483 for OnePacs, LLC on December 02, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OnePacs, LLC
- Inspection Date: 2025-12-02
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of OnePacs, LLC in Machesney Park, IL, a manufacturer of OnePACS software, revealed significant deficiencies in their quality system. The firm failed to adequately establish and follow procedures for design validation, corrective and preventive actions, management review, and quality audits. These issues indicate a systemic lack of proper documentation and adherence to established quality processes.

## Related Officers

- [Shawn Choi](https://www.keypedia.com/people/shawn-choi/77845db3-46a3-4d0f-b94c-428bc251c0dc)

Company: https://www.keypedia.com/companies/onepacs-llc/1ff6fc4e-8fca-4da9-aa13-46bfdce87ff5

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669