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Facility profile

Amgen Manufacturing Limited LLC

Testing & analysis · Drug product manufacturing · Juncos, PR

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
Voluntary action indicated (VAI)

Jul 5, 2023 · 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 history19 inspection records

FDA inspection history

19 records, Jun 2009 – Jul 2023 · 4 NAI · 15 VAI · 0 OAI

DateClassProject areaCitationsFY
Jul 5, 2023VAIDrug Quality AssuranceYes2023
Apr 11, 2019VAICompliance: DevicesYes2019
Apr 11, 2019VAIDrug Quality AssuranceYes2019
Aug 6, 2018VAIDrug Quality AssuranceYes2018
May 10, 2017VAIDrug Quality AssuranceYes2017
Feb 11, 2015VAIDrug Quality Assurance2015
Jan 23, 2015VAIDrug Quality Assurance2015
Aug 15, 2013NAICompliance: DevicesYes2013
Aug 15, 2013VAIDrug Quality AssuranceYes2013
Mar 29, 2013VAIDrug Quality Assurance2013
Jan 6, 2012VAIDrug Quality Assurance2012
Oct 27, 2011NAIDrug Quality Assurance2012
Apr 29, 2011VAIDrug Quality Assurance2011
Oct 1, 2010VAIDrug Quality AssuranceYes2011
Sep 3, 2010VAIDrug Quality Assurance2010
May 27, 2010NAIDrug Quality Assurance2010
Sep 11, 2009VAIPostmarket Surv. and EpidemiologyYes2009
Sep 11, 2009VAIDrug Quality AssuranceYes2009
Jun 12, 2009NAIDrug Quality Assurance2009

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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