Company
United StatesJanssen Pharmaceuticals Inc., Raritan, NJ – FDA Inspections
Inspection records and compliance data for Janssen Pharmaceuticals Inc. in Raritan, New Jersey. 10 FDA inspections on record, 2 Form 483s, last inspected November 01, 2024.
Company Profile
This profile covers Janssen Pharmaceuticals Inc. based in Raritan, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 0
- VAI
- 2
- NAI
- 7
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected January 15, 2009. Last inspected November 1, 2024.
Most cited issue areas
- Cleaning / Sanitizing / Maintenance1 inspection
- Scientifically sound laboratory controls1 inspection
- Training , Education , Experience overall1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 1, 2024 | Not classified | Biologics | 1252007 |
| December 14, 2023 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1225275 |
| June 17, 2022 | NAI | Human Drugs · Drug Quality Assurance | 1175643 |
| January 26, 2017 | NAI | Human Drugs · Drug Quality Assurance | 998113 |
| January 22, 2016 | NAI | Human Drugs · Bioresearch Monitoring | 965139 |
| May 21, 2013 | NAI | Human Drugs · Bioresearch Monitoring | 833775 |
| June 19, 2012 | NAI | Human Drugs · Drug Quality Assurance | 787093 |
| August 22, 2011 | NAI | Human Drugs · Drug Quality Assurance | 740773 |
| August 6, 2010 | NAI | Human Drugs · Drug Quality Assurance | 674432 |
| January 15, 2009 | VAI | Human Drugs · Drug Quality Assurance | 556188 |
FDA documents
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
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Janssen Diagnostics, LLC
Janssen Research & Development
Janssen Supply Chain, LLC
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Ortho-Clinical Diagnostics, Inc.
Robert S. Falcone, M.D.
Company Information
Name
Janssen Pharmaceuticals Inc.
FEI Number
2211100
Address
1000 U.S. Route 202 South, Raritan, New Jersey 08869, United States
Country
United States
ID: b494dc6e-cfeb-46a2-8c10-e036e6a5a623