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Flextronics International GmbH, Althofen, Austria – FDA Inspections

Inspection records and compliance data for Flextronics International GmbH in Althofen. 3 FDA inspections on record, 1 Form 483, last inspected January 26, 2024.

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Company Profile

This profile covers Flextronics International GmbH based in Althofen, Austria.

FDA Inspection History

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

First inspected February 1, 2013. Last inspected January 26, 2024.

Most cited issue areas

  • Lack of or inadequate procedures1 inspection
  • Records of complaint investigation - UDI1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
January 26, 2024Not classifiedMedical Devices & Rad Health · Compliance: Devices1227966
May 16, 2019Not classifiedMedical Devices & Rad Health1096685
February 1, 2013NAIMedical Devices & Rad Health · Postmarket Assurance: Devices816713
FDA documents

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

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Harps Europe Manufacturing
Prof. Dr. Thomas Brucke
Leonhard Lang Medizintechnik GmbH
Otto Bock Healthcare Products GmbH
Schiller Engineering GmbH
W&H Dentalwerk, GmbH - Site 2
Company Information

Name

Flextronics International GmbH

FEI Number

3006126537

Address

Friesacher Strase 3, Althofen, Austria

Country

Austria

ID: 7e546d91-cf0a-413c-819c-078b60040f3c

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