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Smiths Medical Deutschland, GmbH, Fraureuth, Germany – FDA Inspections

Inspection records and compliance data for Smiths Medical Deutschland, GmbH in Fraureuth. 2 FDA inspections on record, 1 Form 483, last inspected February 09, 2017.

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Company Profile

This profile covers Smiths Medical Deutschland, GmbH based in Fraureuth, Germany.

FDA Inspection History

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

First inspected February 20, 2014. Last inspected February 9, 2017.

Most cited issue areas

  • Investigation of device failures1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
February 9, 2017VAIMedical Devices & Rad Health · Compliance: Devices1003946
February 20, 2014NAIMedical Devices & Rad Health · Postmarket Assurance: Devices868937
FDA documents

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

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Company Information

Name

Smiths Medical Deutschland, GmbH

FEI Number

3005580752

Address

Werdauer Str. 51, Fraureuth, Germany

Country

Germany

ID: 38210b4c-8ddb-4577-a57b-4557a1bde75f

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