# FDA 483 - Sirtex Wilmington LLC - July 10, 2025

Source: https://www.keypedia.com/records/483/sirtex-wilmington-llc/bc544d92-7361-4cb9-9e95-931cee6838a9

> FDA 483 for Sirtex Wilmington LLC on July 10, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sirtex Wilmington LLC
- Inspection Date: 2025-07-10
- Product Type: device
- Office Name: New England District Office
- Summary: 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.

## Related Officers

- [Sunita Pandey](https://www.keypedia.com/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

Company: https://www.keypedia.com/companies/sirtex-wilmington-llc/6a8f8d3b-3634-4b89-9e79-17447bfbfd29

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144