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Facility profile

Alkermes, Inc

Testing & analysis · Drug product manufacturing · Wilmington, OH

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

AnalysisManufacture
Due diligence

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)

Oct 19, 2023 · 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 history11 inspection records

FDA inspection history

11 records, Nov 2009 – Oct 2023 · 8 NAI · 3 VAI · 0 OAI

DateClassProject areaCitationsFY
Oct 19, 2023VAIDrug Quality AssuranceYes2024
Aug 14, 2017NAIDrug Quality Assurance2017
Apr 17, 2015NAIDrug Quality Assurance2015
Apr 17, 2015NAICompliance: Devices2015
Aug 15, 2014NAIDrug Quality Assurance2014
Apr 23, 2014NAIDrug Quality Assurance2014
Sep 23, 2013NAIDrug Quality Assurance2013
Jun 28, 2013VAIDrug Quality AssuranceYes2013
Jun 29, 2012NAIDrug Quality Assurance2012
Nov 4, 2011VAIDrug Quality Assurance2012
Nov 23, 2009NAIDrug Quality Assurance2010

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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