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•United States

Merck Sharp & Dohme LLC, West Point, PA – FDA Inspections

Inspection records and compliance data for Merck Sharp & Dohme LLC in West Point, Pennsylvania. 16 FDA inspections on record (1 OAI), 3 Form 483s, last inspected July 15, 2025.

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Company Profile

This profile covers Merck Sharp & Dohme LLC based in West Point, Pennsylvania, United States.

FDA Inspection History

FDA inspections
16
OAI
1
VAI
12
NAI
0
Unclassified
3
Form 483s
3
Warning letters
0

First inspected February 12, 2009. Last inspected July 15, 2025.

Most cited issue areas

  • Conduct: in accordance with protocol1 inspection
  • Incoming lots - conformance to written specs-1 inspection
  • Instruments, apparatus, et. al. not meeting specs1 inspection

FDA inspections (16)

DateResultFDA center(s)Insp. #
July 15, 2025Not classifiedHuman Drugs1275520
December 12, 2024Not classifiedHuman Drugs1252348
August 23, 2024VAIBiologics · Vaccines and Allergenic Products1229927
July 27, 2021VAIBiologics · Vaccines and Allergenic Products1155052
September 20, 2019VAIBiologics · Vaccines and Allergenic Products1103540
April 30, 2019VAIHuman Drugs · Bioresearch Monitoring1087963
April 28, 2017Not classifiedBiologics1013539
April 17, 2015VAIBiologics · Vaccines and Allergenic Products938141
September 12, 2014VAIHuman Drugs · Drug Quality Assurance895238
February 6, 2013VAIBiologics · Vaccines and Allergenic Products822050
September 20, 2012VAIHuman Drugs · Postmarket Surv. and Epidemiology800482
August 11, 2011VAIHuman Drugs · Drug Quality Assurance737299
April 27, 2011VAIBiologics · Human Cellular, Tissue, and Gene Therapies722464
August 18, 2010VAIHuman Drugs · Drug Quality Assurance680253
August 17, 2010VAIBiologics · Vaccines and Allergenic Products685022
February 12, 2009OAIBiologics · Vaccines and Allergenic Products565350
FDA documents

Form 483s (5)

  • Form 483s · August 23, 2024
  • Form 483s · September 9, 2019
  • Form 483s · April 30, 2019
  • Form 483s · April 17, 2015
  • Form 483s

EIRs (1)

  • EIRs · September 20, 2019
People (6)
Haruhiko Murata
Person
Shuang Tang
Person
Anastasia Offordile
Person
Kelly N. Kerr
Person
Timothy A. McHugh
Person
Anissa M. Cheung
Person
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Pharmacia & Upjohn Company LLC
Bristol-Myers Squibb Company
Pfizer Ireland Pharmaceuticals Unlimited Company
IDT Biologika GmbH
Boehringer Ingelheim Fremont, Inc.
Company Information

Name

Merck Sharp & Dohme LLC

FEI Number

2510592

Address

770 Sumneytown Pike, West Point, Pennsylvania 19486, United States

Country

United States

ID: 842c6e25-ee89-453c-a5b0-6b039c187744

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