FDA 483 - CNS Vital Signs, LLC. - April 17, 2025

An FDA inspection of CNS Vital Signs, LLC. in Morrisville, NC, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for corrective and preventive actions, complaint handling, medical device reporting, quality audits, and management review. These findings indicate a fundamental lack of a robust quality system.