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•United States

Merck Sharp & Dohme LLC, Elkton, VA – FDA Inspections

Inspection records and compliance data for Merck Sharp & Dohme LLC in Elkton, Virginia. 19 FDA inspections on record, 4 Form 483s, last inspected November 21, 2025.

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Company Profile

This profile covers Merck Sharp & Dohme LLC based in Elkton, Virginia, United States.

FDA Inspection History

FDA inspections
19
OAI
0
VAI
12
NAI
5
Unclassified
2
Form 483s
4
Warning letters
0

First inspected September 29, 2009. Last inspected November 21, 2025.

Most cited issue areas

  • Investigations of discrepancies, failures2 inspections
  • Air Supply1 inspection
  • Penicillin processing area not kept separate1 inspection

FDA inspections (19)

DateResultFDA center(s)Insp. #
November 21, 2025Not classifiedBiologics1296670
January 22, 2025Not classifiedHuman Drugs1258902
April 26, 2023NAIBiologics · Vaccines and Allergenic Products1210555
March 4, 2020VAIBiologics · Vaccines and Allergenic Products1123248
June 28, 2019VAIHuman Drugs · Drug Quality Assurance1094564
October 26, 2018VAIBiologics · Vaccines and Allergenic Products1073392
January 19, 2018NAIHuman Drugs · Drug Quality Assurance1044990
April 21, 2017NAIHuman Drugs · Drug Quality Assurance1011631
November 18, 2016VAIBiologics · Vaccines and Allergenic Products996284
September 3, 2015NAIHuman Drugs · Drug Quality Assurance950066
August 21, 2015VAIHuman Drugs · Drug Quality Assurance942216
June 10, 2014VAIBiologics · Vaccines and Allergenic Products896058
September 30, 2013VAIHuman Drugs · Drug Quality Assurance851003
August 24, 2012VAIHuman Drugs · Drug Quality Assurance796034
May 12, 2011VAIHuman Drugs · Drug Quality Assurance722546
November 23, 2010VAIBiologics · Vaccines and Allergenic Products713065
July 9, 2010VAIHuman Drugs · Drug Quality Assurance669019
October 1, 2009NAIAnimal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices619365
September 29, 2009VAIHuman Drugs · Drug Quality Assurance615328
FDA documents

Form 483s (5)

  • Form 483s · January 22, 2025
  • Form 483s · June 28, 2019
  • Form 483s · August 24, 2012
  • Form 483s
  • Form 483s
People (4)
Nebil Al Oumer
Person
Brooke K. Higgins
Person
Justin A. Boyd
Person
David A. Oluwo
Person
Related Companies (10)

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Baxter Healthcare Corporation
Janssen Biotech, Inc.
Cis Bio International
MSD Ireland (Carlow)
Polymun Scientific Immunbiologische Forschung GmbH
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Company Information

Name

Merck Sharp & Dohme LLC

FEI Number

1112271

Address

2778 South East Side Hwy, Elkton, Virginia 22827, United States

Country

United States

ID: a9539664-d21e-42b0-9b17-b399cf4873ef

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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