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  5. Merck & Co. Inc (NYSE: MRK), Rahway, NJ – FDA Inspections
Company
•United States•Public company, NYSE: MRK

Merck & Co. Inc (NYSE: MRK), Rahway, NJ – FDA Inspections

Inspection records and compliance data for Merck & Co. Inc in Rahway, New Jersey. 16 FDA inspections on record (1 OAI), 2 Form 483s, last inspected August 14, 2026. Publicly traded as NYSE: MRK.

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Company Profile

This profile covers Merck & Co. Inc based in Rahway, New Jersey, United States.

FDA Inspection History

FDA inspections
16
OAI
1
VAI
5
NAI
5
Unclassified
5
Form 483s
2
Warning letters
0

First inspected August 25, 2011. Last inspected August 14, 2026.

Most cited issue areas

  • General responsibilities of sponsors5 inspections
  • Notification of FDA of termination of investigator2 inspections
  • Record retention requirement2 inspections

FDA inspections (16)

DateResultFDA center(s)Insp. #
August 14, 2026Not classifiedHuman Drugs1329118
March 13, 2026Not classifiedHuman Drugs1305632
December 18, 2025Not classifiedBiologics1283890
May 16, 2025Not classifiedHuman Drugs1262774
March 27, 2025Not classifiedHuman Drugs1264192
November 18, 2021NAIHuman Drugs · Drug Quality Assurance1158317
October 27, 2021NAIHuman Drugs · Bioresearch Monitoring1156008
September 6, 2019NAIHuman Drugs · Bioresearch Monitoring1101464
October 30, 2017VAIHuman Drugs · Bioresearch Monitoring1030306
December 6, 2016NAIHuman Drugs · Bioresearch Monitoring997036
August 26, 2016VAIHuman Drugs · Bioresearch Monitoring989105
November 19, 2015VAIHuman Drugs · Bioresearch Monitoring955689
February 23, 2015OAIHuman Drugs · Bioresearch Monitoring917872
May 19, 2014VAIHuman Drugs · Bioresearch Monitoring882774
October 16, 2013VAIHuman Drugs · Bioresearch Monitoring851594
August 25, 2011NAIHuman Drugs · Drug Quality Assurance741019
FDA documents

Form 483s (2)

  • Form 483s · August 26, 2016
  • Form 483s · November 19, 2015

EIRs (1)

  • EIRs · September 6, 2019
People (6)
Christina Burkhart
Person
Cynthia Kleppinger
Person
Nina Yang
Person
Shirley S. Wen
Person
Mary Ellen Monahan
Person
Steven Talerico
Person
Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Boehringer Ingelheim Pharmaceuticals, Inc.
Patheon Biologics (NJ) LLC
Ranbaxy Inc.
Clario Inc
Bristol Myers Squibb
Amneal Pharmaceuticals, Llc
Ascend Laboratories, LLC
Sandoz Incorporated
Dario D. Altamirano, DO
Daniel J. DeAngelo, MD
Company Information

Name

Merck & Co. Inc

Stock ticker

MRK

Exchange

NYSE

Share price

$146.99

Market cap

$362.4B

Price as of

November 13, 2026

FEI Number

2211017

Address

126 E Lincoln Ave, Rahway, New Jersey 07065, United States

Country

United States

ID: a46a094a-b27d-49bf-bde5-42441f92c622

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