FDA Inspection
Sirtex Wilmington LLCSirtex Wilmington LLC – FDA Inspection, Jul 12, 2013
Record Details
This FDA Inspection record concerns Sirtex Wilmington LLC, with an inspection on July 12, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sirtex Wilmington LLC
- Inspection Date
- July 12, 2013
- Product Type
- Devices
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ID · 8d76d4d7-0bda-4ea4-a725-7c34d36c36d6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 840306
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
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Other FDA inspections of Sirtex Wilmington LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2025 | VAI | New England District Office | Compliance: Medical Devices |
| May 10, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 30, 2009 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Sirtex Wilmington LLC
- FDA Inspection 1267696 - 2025-07-10
- FDA Inspection 723153 - 2011-05-10
- FDA Inspection 578579 - 2009-01-30
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