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Walz Elektronik Gmbh, Rohrdorf, Germany – FDA Inspections

Inspection records and compliance data for Walz Elektronik Gmbh in Rohrdorf. 1 FDA inspection on record, 1 Form 483, last inspected September 10, 2026.

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Company Profile

This profile covers Walz Elektronik Gmbh based in Rohrdorf, Germany.

FDA Inspection History

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

Inspected September 10, 2026.

Most cited issue areas

  • Design and development validation not performed as planned1 inspection
  • Lack of justification for not investigating complaints requiring investigation1 inspection
  • UDI was not recorded for each medical device or batch1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
September 10, 2026Not classifiedMedical Devices & Rad Health · Compliance: Devices1335100
FDA documents

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

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Epigenomics
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AGFA-GEVAERT HEALTHCARE GMBH
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Company Information

Name

Walz Elektronik Gmbh

FEI Number

1000161819

Address

Walddorfer Str. 40, Rohrdorf, Germany

Country

Germany

ID: a38524ed-3773-4f53-a6ca-73dd90274a78

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