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Facility profile

Janssen Biotech, Inc.

Testing & analysis · Drug product manufacturing · Malvern, PA

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed21 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) manufactureManufacture
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)

Jul 29, 2025 · FDA documented observations for voluntary correction.

Matched compliance actions
None in our records

No warning letter, injunction, or seizure matched.

Understand this record

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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 history14 inspection records

FDA inspection history

14 records, Nov 2008 – Jul 2025 · 6 NAI · 8 VAI · 0 OAI

DateClassProject areaCitationsFY
Jul 29, 2025VAIDrug Quality Assurance2025
Mar 10, 2025NAIHuman Cellular, Tissue, and Gene Therapies2025
Nov 30, 2018NAIBioresearch Monitoring2019
Mar 5, 2018VAIDrug Quality Assurance2018
Nov 21, 2017VAIBioresearch MonitoringYes2018
Feb 27, 2017NAIBioresearch Monitoring2017
Aug 19, 2015NAIBioresearch Monitoring2015
Sep 24, 2014VAIDrug Quality Assurance2014
Sep 25, 2012NAIBioresearch Monitoring2012
Jun 15, 2012VAIDrug Quality Assurance2012
May 20, 2011VAIDrug Quality Assurance2011
Oct 26, 2010VAIBioresearch MonitoringYes2011
Aug 18, 2009VAIDrug Quality Assurance2009
Nov 13, 2008NAIBioresearch Monitoring2009

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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