American Regent, Inc. — Shirley, NY

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Listed operations

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

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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 22, 2026

Latest matched inspection

Voluntary action indicated (VAI)

Apr 24, 2024 · 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 history26 inspection records

FDA inspection history

26 records, Dec 2008 – Apr 2024 · 4 NAI · 21 VAI · 1 OAI

DateClassProject areaCitationsFY

Apr 24, 2024VAIMonitoring of Marketed Animal Drugs, Feed, and DevicesYes2024

Apr 24, 2024VAIDrug Quality AssuranceYes2024

Nov 15, 2019NAIMonitoring of Marketed Animal Drugs, Feed, and Devices—2020

Nov 15, 2019NAIDrug Quality Assurance—2020

Apr 11, 2018VAIDrug Quality AssuranceYes2018

Apr 11, 2018VAIMonitoring of Marketed Animal Drugs, Feed, and DevicesYes2018

Feb 28, 2016VAIMonitoring of Marketed Animal Drugs, Feed, and Devices—2016

Feb 28, 2016VAIDrug Quality Assurance—2016

Feb 26, 2016VAIDrug Quality AssuranceYes2016

Feb 26, 2016VAIMonitoring of Marketed Animal Drugs, Feed, and DevicesYes2016

Oct 29, 2014VAIMonitoring of Marketed Animal Drugs, Feed, and DevicesYes2015

Oct 29, 2014VAIFoodborne Biological HazardsYes2015

Oct 29, 2014VAIDrug Quality AssuranceYes2015

Mar 29, 2012VAIMonitoring of Marketed Animal Drugs, Feed, and Devices—2012

Mar 29, 2012VAIDrug Quality Assurance—2012

Mar 15, 2011OAIDrug Quality AssuranceYes2011

Oct 29, 2010VAIMonitoring of Marketed Animal Drugs, Feed, and DevicesYes2011

Oct 29, 2010VAIDrug Quality AssuranceYes2011

Oct 6, 2010NAIPostmarket Assurance: DevicesYes2011

Oct 6, 2010VAIBioresearch MonitoringYes2011

Oct 6, 2010VAICompliance: DevicesYes2011

Nov 5, 2009VAIDrug Quality AssuranceYes2010

Nov 5, 2009VAIMonitoring of Marketed Animal Drugs, Feed, and DevicesYes2010

Dec 16, 2008VAIPostmarket Surv. and EpidemiologyYes2009

Dec 16, 2008VAIDrug Quality AssuranceYes2009

Dec 16, 2008NAIMonitoring of Marketed Animal Drugs, Feed, and DevicesYes2009

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

Matched compliance actions

Aug 31, 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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