FDA 483 - Arthrex, Inc. - January 13, 2025

Arthrex, Inc. in Naples, FL, a specification developer, was cited with two observations during an FDA inspection. The firm failed to adequately establish and implement procedures for receiving, reviewing, and evaluating complaints, with instances of complaints closed without proper investigation. Additionally, the firm did not adequately implement its medical device reportable event procedures, resulting in numerous late reports.