# FDA 483 - Lucas Lifecare LLC - May 13, 2026

Source: https://www.keypedia.com/records/483/lucas-lifecare-llc/eedda0c5-8f97-433b-a1bd-6bd48fa9a20f

> FDA 483 for Lucas Lifecare LLC on May 13, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lucas Lifecare LLC
- Inspection Date: 2026-05-13
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Lucas Lifecare LLC in Janesville, WI, was cited with two observations during an FDA inspection. The firm failed to conduct internal audits at planned intervals to ensure its Quality Management System (QMS) conforms to documented arrangements and is effectively maintained, particularly regarding non-conforming products. Additionally, the company did not adequately establish criteria for evaluating suppliers, specifically lacking a defined frequency for auditing critical suppliers.

## Related Officers

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

Company: https://www.keypedia.com/companies/lucas-lifecare-llc/792cf087-c944-4b70-9729-98114c657f21

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