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Facility profile

Novel Laboratories, Inc.

Testing & analysis · Drug product manufacturing · Somerset, NJ

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

Apr 17, 2026 · FDA documented observations for voluntary correction.

Matched compliance actions
Past action on file · 2021

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 history16 inspection records

FDA inspection history

16 records, Mar 2010 – Apr 2026 · 4 NAI · 11 VAI · 1 OAI

DateClassProject areaCitationsFY
Apr 17, 2026VAIDrug Quality AssuranceYes2026
Oct 10, 2025VAICompliance: DevicesYes2026
May 17, 2024NAIDrug Quality Assurance2024
Jan 13, 2023VAIDrug Quality Assurance2023
Mar 30, 2022VAIDrug Quality Assurance2022
Nov 5, 2020OAIDrug Quality Assurance2021
Nov 8, 2018VAIBioresearch MonitoringYes2019
Feb 23, 2018VAIDrug Quality AssuranceYes2018
Aug 8, 2017VAIDrug Quality Assurance2017
Feb 14, 2017NAIDrug Quality Assurance2017
Nov 17, 2015NAIDrug Quality Assurance2016
Jan 22, 2015NAIBioresearch Monitoring2015
Jun 24, 2014VAIDrug Quality Assurance2014
Aug 26, 2013VAIDrug Quality AssuranceYes2013
Jun 29, 2011VAIDrug Quality Assurance2011
Mar 5, 2010VAIDrug Quality Assurance2010

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

Matched compliance actions

Jun 11, 2021Warning Letter · CDER
Unclaimed profile

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

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