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Facility profile

Baxter Healthcare Corporation

Testing & analysis · Drug product manufacturing · Round Lake, IL

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed15 registered company locations
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.

AnalysisLabelManufacturePackSterilize
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
Official action indicated (OAI)

Apr 2, 2026 · The findings may warrant official FDA action.

Matched compliance actions
Past action on file · 2014

More than five years old · review later records.

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Shows

Registration status and a latest matched official 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 history35 inspection records

FDA inspection history

35 records, Feb 2009 – Apr 2026 · 15 NAI · 13 VAI · 7 OAI

DateClassProject areaCitationsFY
Apr 2, 2026OAIDrug Quality AssuranceYes2026
Aug 1, 2024OAIDrug Quality Assurance2024
Aug 18, 2023VAICompliance: DevicesYes2023
Jul 14, 2017VAIBlood and Blood Products2017
Mar 8, 2017NAIMonitoring of Marketed Animal Drugs, Feed, and Devices2017
Mar 8, 2017NAIDrug Quality Assurance2017
Dec 15, 2016NAIPostmarket Assurance: Devices2017
Dec 15, 2016NAICompliance: Devices2017
Jul 7, 2015VAIBlood and Blood Products2015
Jul 7, 2015VAIDrug Quality Assurance2015
Jun 19, 2015NAIDrug Quality Assurance2015
Jun 19, 2015OAICompliance: Devices2015
Jun 19, 2015NAIMonitoring of Marketed Animal Drugs, Feed, and Devices2015
Sep 17, 2013VAIBlood and Blood Products2013
Jul 29, 2013NAIDrug Quality Assurance2013
Jul 29, 2013OAICompliance: Devices2013
Jul 29, 2013OAIPostmarket Assurance: Devices2013
Jun 7, 2012OAIPostmarket Assurance: DevicesYes2012
Jun 7, 2012OAICompliance: DevicesYes2012
Jun 7, 2012VAIDrug Quality AssuranceYes2012
Mar 18, 2011VAICompliance: DevicesYes2011
Mar 18, 2011VAIPostmarket Assurance: DevicesYes2011
Mar 18, 2011VAIMonitoring of Marketed Animal Drugs, Feed, and DevicesYes2011
Mar 18, 2011VAIDrug Quality AssuranceYes2011
Mar 18, 2011VAIBlood and Blood ProductsYes2011
Sep 22, 2010NAIDrug Quality Assurance2010
Sep 22, 2010NAICompliance: Devices2010
Sep 22, 2010NAIBioresearch Monitoring2010
Sep 2, 2010NAIDrug Quality Assurance2010
Jun 8, 2010NAIDrug Quality Assurance2010
Feb 15, 2010NAIDrug Quality Assurance2010
Feb 15, 2010NAIMonitoring of Marketed Animal Drugs, Feed, and Devices2010
Sep 9, 2009VAIBlood and Blood Products2009
Sep 9, 2009VAIDrug Quality Assurance2009
Feb 13, 2009NAIDrug Quality Assurance2009

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

Matched compliance actions

Jan 17, 2014Warning Letter · CDRH
Unclaimed profile

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