Dion Label Printing, LLC – FDA Inspection, Apr 1, 2026

Record Details

This FDA Inspection record concerns Dion Label Printing, LLC, with an inspection on April 1, 2026, issued by the New England District Office, covering medical devices & rad health.

Company: Dion Label Printing, LLC
Inspection Date: April 1, 2026
Product Type: Medical Devices & Rad Health
Office: New England District Office
Person: Jeffrey J. Thibodeau (FDA Associated Person)

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ID · 487ff3c5-ebbd-41d7-9e91-b8cda5a6609c

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1310412
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Medical Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
ISO 13485:2016 Clause 7.5.8Process for production and service provision not validated
ISO 13485:2016 Clause 7.4.3Purchased product verification activities not established or implemented
ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated

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FDA Inspection

Dion Label Printing, LLCApril 1, 2026