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Facility profile

CELGENE CORPORATION

Testing & analysis · Drug product manufacturing · SUMMIT, NJ

FDA recordFDA directory updated Jul 22, 2026Profile not yet claimed8 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.

AnalysisActive pharmaceutical ingredient (API) manufactureLabelManufacturePack
Due diligence

Regulatory record at a glance

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Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 22, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Jul 18, 2025 · FDA documented observations for voluntary correction.

Matched compliance actions
None in our records

No warning letter, injunction, or seizure matched.

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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, Sep 2009 – Jul 2025 · 11 NAI · 6 VAI · 0 OAI

DateClassProject areaCitationsFY
Jul 18, 2025VAIHuman Cellular, Tissue, and Gene Therapies2025
Dec 6, 2024VAIBioresearch MonitoringYes2025
Sep 6, 2024NAIBioresearch Monitoring2024
Jan 31, 2024NAIBioresearch Monitoring2024
Jun 16, 2023VAIHuman Cellular, Tissue, and Gene TherapiesYes2023
Mar 14, 2022NAIBioresearch Monitoring2022
Jun 3, 2020NAIBioresearch Monitoring2020
Jul 26, 2019NAIBioresearch Monitoring2019
Jul 26, 2019NAIBioresearch Monitoring2019
Jun 27, 2018NAIBioresearch Monitoring2018
Mar 17, 2017NAIBioresearch Monitoring2017
Apr 29, 2014NAIDrug Quality Assurance2014
Jul 30, 2012NAIBioresearch Monitoring2012
Jul 30, 2012VAIDrug Quality Assurance2012
Jun 17, 2011NAIBioresearch Monitoring2011
Mar 19, 2010VAIDrug Quality AssuranceYes2010
Sep 3, 2009VAIBioresearch MonitoringYes2009

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

Matched compliance actions

No warning letter, injunction, or seizure is matched in the current data set.

Unclaimed profile

Service details not yet provided

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

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