FDA 483 - Carolon Company - June 15, 2023

An FDA inspection of Carolon Company in Rural Hall, NC, revealed significant deficiencies across its quality management system for medical device manufacturing. The firm failed to adequately establish and follow procedures for complaint handling, medical device reporting, corrective and preventive actions, non-conforming product control, device history records, and internal quality audits. These findings indicate a systemic breakdown in maintaining compliance with regulatory requirements.