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•United States

Janssen Pharmaceuticals, Inc, Titusville, NJ – FDA Inspections

Inspection records and compliance data for Janssen Pharmaceuticals, Inc in Titusville, New Jersey. 13 FDA inspections on record, 2 Form 483s, last inspected September 25, 2026.

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Company Profile

This profile covers Janssen Pharmaceuticals, Inc based in Titusville, New Jersey, United States.

FDA Inspection History

FDA inspections
13
OAI
0
VAI
2
NAI
10
Unclassified
1
Form 483s
2
Warning letters
0

First inspected April 9, 2009. Last inspected September 25, 2026.

Most cited issue areas

  • Failure to comply with REMS Elements to Assure Safe Use (ETASU) D1 inspection
  • Failure to comply with REMS Implementation System1 inspection
  • No NCIE submitted1 inspection

FDA inspections (13)

DateResultFDA center(s)Insp. #
September 25, 2026VAIHuman Drugs · Postmarket Surv. and Epidemiology1338168
August 14, 2025Not classifiedHuman Drugs1271223
September 27, 2024NAIHuman Drugs · Bioresearch Monitoring: Human Drugs1229931
September 28, 2020NAIHuman Drugs · Bioresearch Monitoring1131617
September 14, 2020NAIHuman Drugs · Drug Quality Assurance1131381
October 6, 2017NAIMedical Devices & Rad Health · Compliance: Devices1031605
April 22, 2015NAIHuman Drugs · Drug Quality Assurance923153
December 12, 2013NAIHuman Drugs · Bioresearch Monitoring858660
November 16, 2012NAIMedical Devices & Rad Health · Bioresearch Monitoring807491
June 28, 2012NAIHuman Drugs · Drug Quality Assurance788844
June 1, 2011NAIHuman Drugs · Drug Quality Assurance726281
December 9, 2010VAIAnimal Drugs & Feeds · Bioresearch Monitoring700696
April 9, 2009NAIHuman Drugs · Drug Quality Assurance572789
FDA documents

Form 483s (1)

  • Form 483s · September 27, 2024

EIRs (1)

  • EIRs · September 27, 2024

Other FDA documents (1)

  • Other FDA documents
People (3)
Jay B. Shah
Person
Kellie B. Kelm
Person
Yvonne Wu, Ph.D.
Person
Related Companies (10)

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INFINITY-EKG LIFE SCIENCES MO LLC
Astellas Pharma US Inc.
Aptar France SAS
Bioagilytix Labs LLC
Pine Lake Investments, Inc.
Company Information

Name

Janssen Pharmaceuticals, Inc

FEI Number

2242843

Address

1125 Trenton Harbourton Rd, Titusville, New Jersey 08560, United States

Country

United States

ID: 7d87f794-c8cc-4a2c-b985-4d62ebc2d60b

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Contact
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