FDA Inspection
William Cook Europe ApSWilliam Cook Europe ApS – FDA Inspection, Dec 9, 2016
Record Details
This FDA Inspection record concerns William Cook Europe ApS, with an inspection on December 9, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 927a0545-0e8c-4494-bcc0-71bb3f60b8c9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 996912
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of William Cook Europe ApS
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2026 | Not classified | Office of Inspections and Investigations | |
| November 6, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 12, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 28, 2009 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for William Cook Europe ApS
- FDA Inspection 1340692 - 2026-09-17
- FDA Inspection 905322 - 2014-11-06
- FDA Inspection 743988 - 2011-08-12
- FDA Inspection 589141 - 2009-05-28
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