Company
BelgiumJanssen Pharmaceutica NV, Olen, Belgium – FDA Inspections
Inspection records and compliance data for Janssen Pharmaceutica NV in Olen. 5 FDA inspections on record, last inspected October 07, 2025.
Company Profile
This profile covers Janssen Pharmaceutica NV based in Olen, Belgium.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 8, 2009. Last inspected October 7, 2025.
Most cited issue areas
- Deviations from laboratory control requirements1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 7, 2025 | Not classified | Human Drugs | 1302316 |
| February 3, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1220158 |
| May 16, 2014 | VAI | Human Drugs · Drug Quality Assurance | 878913 |
| May 10, 2012 | NAI | Human Drugs · Drug Quality Assurance | 785854 |
| June 8, 2009 | NAI | Human Drugs · Drug Quality Assurance | 591562 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Janssen Pharmaceutica NV
FEI Number
3002807334
Address
Lammerdries 55, Olen, Belgium
Country
Belgium
ID: d5daf032-e000-46a3-bc73-57fab90fd2ae