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Fetzer Medical GmbH & Co. KG, Tuttlingen, Germany – FDA Inspections

Inspection records and compliance data for Fetzer Medical GmbH & Co. KG in Tuttlingen. 2 FDA inspections on record, 2 Form 483s, last inspected July 03, 2025.

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Company Profile

This profile covers Fetzer Medical GmbH & Co. KG based in Tuttlingen, Germany.

FDA Inspection History

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

First inspected September 27, 2018. Last inspected July 3, 2025.

Most cited issue areas

  • Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
  • Lack of or inadequate final acceptance procedures1 inspection
  • Lack of or inadequate procedures1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
July 3, 2025Not classifiedMedical Devices & Rad Health · Compliance: Medical Devices1275801
September 27, 2018VAIMedical Devices & Rad Health · Compliance: Devices1066868
FDA documents

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

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Company Information

Name

Fetzer Medical GmbH & Co. KG

FEI Number

3007648354

Address

Unter Buchsteig 5, Tuttlingen, Germany

Country

Germany

ID: 9804fdf2-fe6d-4177-a931-e259c7acaac6

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