Labverity
Facility profile

Sunstar Americas, Inc.

Packaging & labeling · Schaumburg, IL

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed
Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

LabelPackRelabelRepack
Due diligence

Regulatory record at a glance

Use these records to guide qualification; they are not a facility score.

Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Feb 10, 2023 · FDA documented observations for voluntary correction.

Matched compliance actions
Warning Letter · Dec 2021

Within five years · review the action and follow-up.

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Shows

Registration status and a latest matched voluntary action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

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Method and source details
View full inspection and compliance history12 inspection records

FDA inspection history

12 records, Oct 2011 – Feb 2023 · 8 NAI · 2 VAI · 2 OAI

DateClassProject areaCitationsFY
Feb 10, 2023VAICompliance: DevicesYes2023
Feb 10, 2023VAIPostmarket Assurance: DevicesYes2023
Feb 18, 2021OAIDrug Quality Assurance2021
Feb 18, 2021NAIPostmarket Assurance: Devices2021
Feb 18, 2021OAICompliance: Devices2021
Jun 6, 2016NAIHuman Cellular, Tissue, and Gene Therapies2016
Dec 16, 2014NAICompliance: Devices2015
Dec 16, 2014NAIPostmarket Assurance: Devices2015
Dec 3, 2013NAIHuman Cellular, Tissue, and Gene Therapies2014
Dec 20, 2011NAIDrug Quality Assurance2012
Oct 27, 2011NAICompliance: Devices2012
Oct 27, 2011NAIPostmarket Assurance: Devices2012

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

Dec 21, 2021Warning Letter · CDER
Unclaimed profile

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