Company
United StatesJanssen Biotech, Inc., Malvern, PA – FDA Inspections
Inspection records and compliance data for Janssen Biotech, Inc. in Malvern, Pennsylvania. 15 FDA inspections on record, 3 Form 483s, last inspected July 29, 2025.
Company Profile
This profile covers Janssen Biotech, Inc. based in Malvern, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 15
- OAI
- 0
- VAI
- 7
- NAI
- 6
- Unclassified
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected November 13, 2008. Last inspected July 29, 2025.
Most cited issue areas
- General responsibilities of sponsors1 inspection
- Investigator non-compliance1 inspection
FDA inspections (15)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 29, 2025 | Not classified | Human Drugs | 1276933 |
| March 10, 2025 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1265723 |
| November 30, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1077487 |
| March 5, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1046499 |
| November 21, 2017 | VAI | Human Drugs · Bioresearch Monitoring | 1031776 |
| September 22, 2017 | Not classified | Human Drugs | 1027122 |
| February 27, 2017 | NAI | Human Drugs · Bioresearch Monitoring | 1007329 |
| August 19, 2015 | NAI | Human Drugs · Bioresearch Monitoring | 939172 |
| September 24, 2014 | VAI | Human Drugs · Drug Quality Assurance | 897031 |
| September 25, 2012 | NAI | Human Drugs · Bioresearch Monitoring | 801737 |
| June 15, 2012 | VAI | Human Drugs · Drug Quality Assurance | 789675 |
| May 20, 2011 | VAI | Human Drugs · Drug Quality Assurance | 729112 |
| October 26, 2010 | VAI | Human Drugs · Bioresearch Monitoring | 685099 |
| August 18, 2009 | VAI | Human Drugs · Drug Quality Assurance | 605645 |
| November 13, 2008 | NAI | Human Drugs · Bioresearch Monitoring | 546741 |
FDA documents
People (4)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Janssen Biotech, Inc.
FEI Number
3001610451
Address
200 Great Valley Pkwy, Malvern, Pennsylvania 19355, United States
Country
United States
ID: 5374365d-a0df-4a87-ad3d-2714628d3e57