Company
United StatesSirtex Wilmington LLC, Wilmington, MA – FDA Inspections
Inspection records and compliance data for Sirtex Wilmington LLC in Wilmington, Massachusetts. 4 FDA inspections on record, 1 Form 483, last inspected July 10, 2025.
Company Profile
This profile covers Sirtex Wilmington LLC based in Wilmington, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 30, 2009. Last inspected July 10, 2025.
Most cited issue areas
- Report of Death or Serious Injury2 inspections
- Contamination control, Lack of or inadequate procedures1 inspection
- Design control - no procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 10, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1267696 |
| July 12, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 840306 |
| May 10, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 723153 |
| January 30, 2009 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 578579 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Sirtex Wilmington LLC
FEI Number
3005579300
Address
16 Upton Dr Unit 2-4, Wilmington, Massachusetts 01887, United States
Country
United States
ID: 6a8f8d3b-3634-4b89-9e79-17447bfbfd29