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Laerdal Medical A/S, Stavanger, Norway – FDA Inspections

Inspection records and compliance data for Laerdal Medical A/S in Stavanger. 3 FDA inspections on record, last inspected November 10, 2016.

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Company Profile

This profile covers Laerdal Medical A/S based in Stavanger, Norway.

FDA Inspection History

FDA inspections
3
OAI
0
VAI
2
NAI
1
Form 483s
0
Warning letters
0

First inspected June 23, 2011. Last inspected November 10, 2016.

Most cited issue areas

  • Investigation of device failures1 inspection
  • Lack of or inadequate complaint procedures1 inspection
  • Lack of or inadequate procedures1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
November 10, 2016NAIMedical Devices & Rad Health · Compliance: Devices994026
August 22, 2013VAIMedical Devices & Rad Health · Compliance: Devices845097
June 23, 2011VAIMedical Devices & Rad Health · Postmarket Assurance: Devices738432
FDA documents

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

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Premier Suburban Medical Group - Orland Park Medical Pavilion
Company Information

Name

Laerdal Medical A/S

FEI Number

3002807435

Address

Tanke Svilandsgate 30,, Stavanger, Norway

Country

Norway

ID: 9e58f4ff-ff76-4e29-ae38-f001bf46098e

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