FDA 483 - Plexus Corp. - January 22, 2025

Plexus Corp. in Neenah, WI, a contract medical device manufacturer, was cited with two observations during an FDA inspection. The firm's corrective and preventive action procedures were found inadequate, specifically concerning investigations into product failures and shelf-life issues. Additionally, procedures for receiving, reviewing, and evaluating complaints were not adequately established, lacking proper risk assessment and documentation for containment actions.