# Dion Label Printing, LLC – FDA 483, Apr 1, 2026

Source: https://www.keypedia.com/records/483/dion-label-printing-llc/776e627c-95ca-488e-9ad8-b399b7292927

> FDA 483 for Dion Label Printing, LLC on April 01, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dion Label Printing, LLC
- Inspection Date: 2026-04-01
- Product Type: device
- Office Name: New England District Office
- Summary: Dion Label Printing, LLC, a medical device manufacturer in Westfield, MA, received a Form 483 with three observations. The inspection revealed significant deficiencies in risk management documentation, process validation for a Class II medical device, and supplier control. These issues indicate a lack of adequate quality system controls for their medical device manufacturing operations.

## Related Officers

- [Power Trader/Data Scientist](https://www.keypedia.com/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.keypedia.com/companies/dion-label-printing-llc/885aa515-2ecf-4f59-88a6-72bfb74a5d54

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144