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Facility profile

Elite Laboratories, Inc.

Drug product manufacturing · Northvale, NJ

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed
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Listed operations

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LabelManufacture
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)

Aug 1, 2025 · FDA documented observations for voluntary correction.

Matched compliance actions
Past action on file · 2016

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

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Method and source details
View full inspection and compliance history12 inspection records

FDA inspection history

12 records, Apr 2011 – Aug 2025 · 3 NAI · 8 VAI · 1 OAI

DateClassProject areaCitationsFY
Aug 1, 2025VAIDrug Quality Assurance2025
Mar 13, 2020VAIBioresearch MonitoringYes2020
Mar 13, 2020VAIBioresearch MonitoringYes2020
Jan 21, 2020NAIDrug Quality Assurance2020
Feb 2, 2018NAIDrug Quality Assurance2018
Dec 4, 2017NAIDrug Quality Assurance2018
Apr 24, 2017VAIDrug Quality Assurance2017
Apr 24, 2017VAIPostmarket Surv. and Epidemiology2017
Feb 2, 2016OAIBioresearch Monitoring2016
Jun 3, 2014VAIDrug Quality Assurance2014
Aug 14, 2012VAIDrug Quality Assurance2012
Apr 28, 2011VAIDrug Quality Assurance2011

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

Matched compliance actions

Aug 25, 2016Warning Letter · CDER
Unclaimed profile

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