FDA 483 - Plexus Corp. - January 22, 2025

Plexus Corp., a contract medical device manufacturer in Neenah, WI, underwent an FDA inspection from January 15 to January 22, 2025. The inspection revealed significant deficiencies in the company's quality system, primarily concerning corrective and preventive actions (CAPA) and complaint handling procedures.

Observation 1 cited inadequate CAPA procedures. Specifically, an investigation into cracked capacitors causing field failures in a Class II cardiac monitoring device was insufficient; the root cause remained unknown after a supplier refused to cooperate, and Plexus failed to assess the broader impact of this supplier's components. Additionally, an investigation into Class II infusion delivery device batteries shipped past their shelf-life was inadequate, as it did not determine why the specification was missed.

Observation 2 highlighted inadequate complaint handling procedures. The company's SOP lacked clear requirements for determining and documenting complaint risk, leading to several reviewed complaint records missing documented risk assessments or rationale for not implementing containment actions. These issues predominantly involved infusion delivery devices.

These observations indicate non-compliance with FDA medical device quality system requirements. Plexus Corp. is expected to address these deficiencies by implementing comprehensive corrective actions to ensure regulatory adherence and prevent recurrence.