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MALSCH GMBH, Wildeck, Germany – FDA Inspections

Inspection records and compliance data for MALSCH GMBH in Wildeck. 1 FDA inspection on record, 1 Form 483, last inspected December 21, 2023.

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Company Profile

This profile covers MALSCH GMBH based in Wildeck, Germany.

FDA Inspection History

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

Inspected December 21, 2023.

Most cited issue areas

  • Design validation - user needs and intended uses1 inspection
  • Devices subject to device identification GUDID data submission requirements.1 inspection
  • Lack of or inadequate complaint procedures1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
December 21, 2023VAIMedical Devices & Rad Health · Compliance: Devices1226550
FDA documents

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

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Company Information

Name

MALSCH GMBH

FEI Number

3011670571

Address

Rohbergstr. 9, Wildeck, Germany

Country

Germany

ID: c5c5dfe8-0e59-4692-8723-149a91745bb1

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