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Facility profile

Baxter Healthcare Corporation

Testing & analysis · Drug product manufacturing · Guayama, PR

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.

AnalysisActive pharmaceutical ingredient (API) manufactureLabelManufacturePackRelabelRepack
Due diligence

Regulatory record at a glance

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Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Mar 26, 2025 · FDA documented observations for voluntary correction.

Matched compliance actions
Past action on file · 2011

More than five years old · review later records.

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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 history16 inspection records

FDA inspection history

16 records, Sep 2010 – Mar 2025 · 10 NAI · 4 VAI · 2 OAI

DateClassProject areaCitationsFY
Mar 26, 2025VAIDrug Quality AssuranceYes2025
Sep 16, 2020NAIMonitoring of Marketed Animal Drugs, Feed, and Devices2020
Oct 24, 2018VAIMonitoring of Marketed Animal Drugs, Feed, and DevicesYes2019
Oct 24, 2018VAIDrug Quality AssuranceYes2019
Dec 13, 2016NAIDrug Quality Assurance2017
Dec 13, 2016NAIMonitoring of Marketed Animal Drugs, Feed, and Devices2017
Feb 6, 2015NAIMonitoring of Marketed Animal Drugs, Feed, and DevicesYes2015
Feb 6, 2015VAIDrug Quality AssuranceYes2015
Dec 4, 2013NAIMonitoring of Marketed Animal Drugs, Feed, and Devices2014
Dec 4, 2013NAIDrug Quality Assurance2014
May 18, 2012NAIDrug Quality Assurance2012
May 18, 2012NAIMonitoring of Marketed Animal Drugs, Feed, and Devices2012
Jun 30, 2011NAIMonitoring of Marketed Animal Drugs, Feed, and Devices2011
Jun 30, 2011NAIDrug Quality Assurance2011
Sep 30, 2010OAIDrug Quality Assurance2010
Sep 30, 2010OAIMonitoring of Marketed Animal Drugs, Feed, and Devices2010

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

Matched compliance actions

Jan 20, 2011Warning Letter · CDER
Unclaimed profile

Service details not yet provided

Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

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