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Facility profile

Baxter Healthcare Corporation

Testing & analysis · Drug product manufacturing · Jayuya, 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.

AnalysisLabelManufacturePackSterilize
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)

Jul 19, 2024 · FDA documented observations for voluntary correction.

Matched compliance actions
Past action on file · 2013

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, Apr 2009 – Jul 2024 · 7 NAI · 4 VAI · 5 OAI

DateClassProject areaCitationsFY
Jul 19, 2024VAIDrug Quality Assurance2024
Jul 30, 2021NAIDrug Quality Assurance2021
Dec 21, 2018VAIDrug Quality AssuranceYes2019
Oct 3, 2016OAIDrug Quality Assurance2017
May 1, 2015OAIDrug Quality AssuranceYes2015
Feb 11, 2014OAIDrug Quality AssuranceYes2014
Sep 26, 2013NAIDrug Quality Assurance2013
Sep 26, 2013NAIFoodborne Biological Hazards2013
Apr 19, 2013OAIDrug Quality AssuranceYes2013
Nov 3, 2011VAIDrug Quality AssuranceYes2012
Apr 27, 2011NAIDrug Quality Assurance2011
Aug 26, 2010OAIDrug Quality AssuranceYes2010
May 14, 2009NAIBioresearch Monitoring2009
May 14, 2009VAIDrug Quality Assurance2009
Apr 17, 2009NAIDrug Quality Assurance2009
Apr 17, 2009NAIPostmarket Surv. and Epidemiology2009

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

Matched compliance actions

May 31, 2013Warning Letter · CDER
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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