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Facility profile

Merck Sharp & Dohme LLC

Testing & analysis · Drug product manufacturing · Elkton, VA

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed23 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) manufactureManufactureSalvageSterilize
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)

Jan 22, 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 history19 inspection records

FDA inspection history

19 records, Sep 2009 – Jan 2025 · 5 NAI · 14 VAI · 0 OAI

DateClassProject areaCitationsFY
Jan 22, 2025VAIDrug Quality Assurance2025
Apr 26, 2023NAIVaccines and Allergenic Products2023
Mar 4, 2020VAIVaccines and Allergenic Products2020
Jun 28, 2019VAIDrug Quality AssuranceYes2019
Oct 26, 2018VAIVaccines and Allergenic Products2019
Jan 19, 2018NAIDrug Quality Assurance2018
Apr 21, 2017NAIDrug Quality Assurance2017
Nov 18, 2016VAIVaccines and Allergenic Products2017
Sep 3, 2015NAIDrug Quality Assurance2015
Aug 21, 2015VAIDrug Quality Assurance2015
Jun 10, 2014VAIVaccines and Allergenic Products2014
Sep 30, 2013VAIDrug Quality Assurance2013
Aug 24, 2012VAIDrug Quality AssuranceYes2012
May 12, 2011VAIDrug Quality Assurance2011
Nov 23, 2010VAIVaccines and Allergenic Products2011
Jul 9, 2010VAIDrug Quality Assurance2010
Oct 1, 2009NAIMonitoring of Marketed Animal Drugs, Feed, and Devices2010
Oct 1, 2009VAIDrug Quality Assurance2010
Sep 29, 2009VAIDrug Quality AssuranceYes2009

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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