483
Lucas Lifecare LLCLucas Lifecare LLC – FDA 483, May 13, 2026
Record Details
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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