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4DMedical Ltd., Carlton, Australia – FDA Inspections

Inspection records and compliance data for 4DMedical Ltd. in Carlton. 1 FDA inspection on record, 1 Form 483, last inspected January 08, 2026.

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Company Profile

This profile covers 4DMedical Ltd. based in Carlton, Australia.

FDA Inspection History

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

Inspected January 8, 2026.

Most cited issue areas

  • Design verification - Lack of or inadequate procedures1 inspection
  • Lack of or inadequate complaint procedures1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
January 8, 2026Not classifiedMedical Devices & Rad Health · Compliance: Medical Devices1299338
FDA documents

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

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Cochlear Limited - Brisbane
Global Manufacturing Technology Pty Ltd.
Planet Innovation Pty Ltd
Company Information

Name

4DMedical Ltd.

FEI Number

3017426576

Address

L 7 700 Swanston Street, Carlton, Australia

Country

Australia

ID: 9a5a4824-8449-4aa9-b162-550f1a5e4d10

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