William Cook Europe ApS, Bjaverskov, Denmark – FDA Inspections

Inspection records and compliance data for William Cook Europe ApS in Bjaverskov. 5 FDA inspections on record, 1 Form 483, last inspected September 17, 2026.

Company Profile

This profile covers William Cook Europe ApS based in Bjaverskov, Denmark.

FDA Inspection History

FDA inspections: 5
OAI: 0
VAI: 1
NAI: 3
Unclassified: 1
Form 483s: 1
Warning letters: 0

First inspected May 28, 2009. Last inspected September 17, 2026.

Most cited issue areas

Complaints1 inspection
Lack of or inadequate procedures1 inspection

FDA inspections (5)

Date	Result	FDA center(s)	Insp. #
September 17, 2026	Not classified	Medical Devices & Rad Health	1340692
December 9, 2016	VAI	Medical Devices & Rad Health · Project Evaluation: Devices	996912
November 6, 2014	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	905322
August 12, 2011	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	743988
May 28, 2009	NAI	Medical Devices & Rad Health · Bioresearch Monitoring	589141

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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