Sabre Medical Pty. Ltd. – FDA Inspection, May 22, 2025

Record Details

This FDA Inspection record concerns Sabre Medical Pty. Ltd., with an inspection on May 22, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Sabre Medical Pty. Ltd.
Inspection Date: May 22, 2025
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Marvin A. Marenco (Issuing Officer)

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ID · 840f2fec-3998-4eed-b7df-9a94ba9d90d6

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1270789
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.70(c)Environmental control Lack of or inadequate procedures

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FDA Inspection

Sabre Medical Pty. Ltd.May 22, 2025