FDA Inspection
Sirtex Wilmington LLCSirtex Wilmington LLC – FDA Inspection, Jan 30, 2009
Record Details
This FDA Inspection record concerns Sirtex Wilmington LLC, with an inspection on January 30, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sirtex Wilmington LLC
- Inspection Date
- January 30, 2009
- Product Type
- Devices
View Company Profile
ID · 62c043b0-3fba-4705-b16a-f6758b4f14de
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 578579
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sirtex Wilmington LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2025 | VAI | New England District Office | Compliance: Medical Devices |
| July 12, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 10, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sirtex Wilmington LLC
- FDA Inspection 1267696 - 2025-07-10
- FDA Inspection 840306 - 2013-07-12
- FDA Inspection 723153 - 2011-05-10
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