483
Sirtex Wilmington LLCSirtex Wilmington LLC – FDA 483, Jul 10, 2025
Record Details
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.
- Person
View Company Profile
ID · bc544d92-7361-4cb9-9e95-931cee6838a9
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.