Drug factory · FDA FEI 3002807334
Janssen Pharmaceutica NV
Lammerdries 55, Olen, Belgium
Problems found, fixed voluntarily at FDA's last inspection, Oct 7, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2009: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Itraconazole | Makes it | Janssen Pharmaceuticals, Inc., Patriot Pharmaceuticals | 50458-290, 10147-1700 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 7, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 3, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 16, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| May 10, 2012 | No problems found | Drug Quality Assurance | — |
| Jun 8, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
May 16, 2014 inspection
- Deviations from laboratory control requirements 21 CFR 211.160(a)
Deviations from written test procedures are not recorded and justified.
Registered with FDA for: manufacture.