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Amgen, Inc

Testing & analysis · Drug product manufacturing · Thousand Oaks, CA

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed9 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

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
No action indicated (NAI)

Aug 7, 2025 · No conditions warranted FDA action in this inspection.

Matched compliance actions
Past action on file · 2014

More than five years old · review later records.

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Shows

Registration status and a latest matched no 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 history27 inspection records

FDA inspection history

27 records, May 2009 – Aug 2025 · 20 NAI · 6 VAI · 1 OAI

DateClassProject areaCitationsFY
Aug 7, 2025NAIBioresearch Monitoring2025
Mar 13, 2025VAIDrug Quality AssuranceYes2025
Sep 14, 2023NAIBioresearch Monitoring2023
Dec 13, 2019VAIDrug Quality AssuranceYes2020
Aug 21, 2017NAICompliance: Devices2017
Apr 19, 2017NAIBioresearch Monitoring2017
Apr 19, 2017NAIDrug Quality Assurance2017
Mar 17, 2017NAIBioresearch Monitoring2017
Sep 1, 2016NAIBioresearch Monitoring2016
Apr 13, 2016NAIBioresearch Monitoring2016
Feb 12, 2016NAIBioresearch Monitoring2016
May 22, 2015VAIDrug Quality Assurance2015
Nov 14, 2014NAIBioresearch Monitoring2015
Sep 17, 2014NAIBioresearch Monitoring2014
Aug 27, 2014NAICompliance: Devices2014
Aug 27, 2014NAIBioresearch Monitoring2014
Aug 27, 2014NAIDrug Quality Assurance2014
Jul 25, 2013NAIBioresearch Monitoring2013
Jun 17, 2013OAICompliance: DevicesYes2013
Jun 17, 2013NAIPostmarket Assurance: DevicesYes2013
Dec 12, 2012VAIDrug Quality Assurance2013
Dec 12, 2012NAIBioresearch Monitoring2013
Dec 12, 2012VAIBioresearch MonitoringYes2013
May 20, 2011NAIBioresearch Monitoring2011
Nov 17, 2010NAIBioresearch Monitoring2011
Jun 3, 2010VAIBioresearch MonitoringYes2010
May 1, 2009NAIBioresearch Monitoring2009

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

Matched compliance actions

Jan 27, 2014Warning Letter · CDER
Unclaimed profile

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