FDA Inspection 1310412 - Dion Label Printing, LLC - April 01, 2026

FDA Inspection 1310412 for Dion Label Printing, LLC on April 01, 2026. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1310412 for Dion Label Printing, LLC on April 01, 2026. Classification: Voluntary Action Indicated (VAI).

Violation Codes

ISO 13485:2016 Clause 7.1

ISO 13485:2016 Clause 7.4.3

ISO 13485:2016 Clause 7.5.6

ISO 13485:2016 Clause 7.5.8

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Record Information

Company

Dion Label Printing, LLC

Inspection Date

April 1, 2026

Product Type

Medical Devices & Rad Health

Office

Center for Devices and Radiological Health

ID: 244b8429-f8dd-462e-8042-7eb3fca75fb7

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