FDA 483 - Sirtex Wilmington LLC - July 10, 2025

The FDA inspection of Sirtex Wilmington LLC revealed significant deficiencies across multiple quality system areas related to their LAVA Liquid Embolic System. The firm failed to establish adequate procedures for design control, process validation, supplier management, corrective and preventive actions (CAPA), complaint handling, and Medical Device Reporting (MDR). These issues indicate a systemic breakdown in ensuring the safety and effectiveness of their medical devices.