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Facility profile

Fresenius Kabi USA, LLC

Testing & analysis · Drug product manufacturing · Grand Island, NY

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed4 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.

AnalysisManufacture
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)

Oct 13, 2023 · FDA documented observations for voluntary correction.

Matched compliance actions
Past action on file · 2012

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 history17 inspection records

FDA inspection history

17 records, Oct 2008 – Oct 2023 · 4 NAI · 11 VAI · 2 OAI

DateClassProject areaCitationsFY
Oct 13, 2023VAIDrug Quality AssuranceYes2024
Aug 30, 2023NAIPostmarket Assurance: DevicesYes2023
Aug 30, 2023VAICompliance: DevicesYes2023
Aug 12, 2019VAIDrug Quality Assurance2019
Mar 30, 2017VAIDrug Quality Assurance2017
Mar 30, 2017NAIBioresearch Monitoring2017
Feb 1, 2017VAIDrug Quality Assurance2017
Feb 4, 2016VAIDrug Quality AssuranceYes2016
Oct 24, 2014VAIFoodborne Biological HazardsYes2015
Oct 24, 2014VAIDrug Quality AssuranceYes2015
Jan 11, 2013OAIDrug Quality AssuranceYes2013
Aug 29, 2011VAIDrug Quality Assurance2011
Jul 8, 2011OAIDrug Quality Assurance2011
Jan 13, 2010VAIDrug Quality AssuranceYes2010
Sep 17, 2009VAIDrug Quality Assurance2009
Mar 5, 2009NAIDrug Quality Assurance2009
Oct 31, 2008NAIDrug Quality Assurance2009

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

Matched compliance actions

Feb 22, 2012Warning 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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