FDA Inspection 1262942 - Anteris Technologies Ltd - February 20, 2025

FDA Inspection 1262942 for Anteris Technologies Ltd on February 20, 2025. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1262942 for Anteris Technologies Ltd on February 20, 2025. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 803.50(a)(2)

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Record Information

Company

Anteris Technologies Ltd

Inspection Date

February 20, 2025

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: f8943c88-de08-4c34-9abd-3bc1461b4695

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