FDA 483 - Lucas Lifecare LLC - May 13, 2026
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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.
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ID · eedda0c5-8f97-433b-a1bd-6bd48fa9a20f