FDA Inspection
Sirtex Wilmington LLCSirtex Wilmington LLC – FDA Inspection, Jul 10, 2025
Record Details
This FDA Inspection record concerns Sirtex Wilmington LLC, with an inspection on July 10, 2025, issued by the New England District Office, covering medical devices & rad health.
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ID · 275bcb44-42ed-4485-a7c2-b73b4e53d386
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1267696
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
6- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Sirtex Wilmington LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2013 | VAI | Center for Devices and Radiological Health | Compliance: 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 840306 - 2013-07-12
- FDA Inspection 723153 - 2011-05-10
- FDA Inspection 578579 - 2009-01-30
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