Barco N.V. – FDA 483, Sep 14, 2023

Barco N.V., a medical device manufacturer, was cited with six observations during an FDA inspection, highlighting significant deficiencies in their quality system. The firm failed to maintain adequate procedures for Medical Device Reporting (MDRs), corrective and preventive actions (CAPA), and complaint handling. Additionally, issues were noted with undocumented personnel training and insufficient controls over critical suppliers, indicating a systemic breakdown in regulatory compliance.