Drug factory · FDA FEI 3002807337
Janssen Pharmaceutica NV
Janssen Pharmaceuticalaan 3, Geel, Belgium
Problems found, fixed voluntarily at FDA's last inspection, Mar 26, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2010: 4 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Abiraterone | Makes the active ingredient |
Janssen Biotech, Inc. |
57894-150, 57894-195 |
| Abiraterone and Niraparib | Makes it, makes the active ingredient and tests it |
Janssen Biotech, Inc. |
57894-050, 57894-100 |
| Apalutamide | Makes it and tests it |
Janssen Products LP |
59676-600, 59676-604 |
| Bedaquiline | Makes the active ingredient |
Janssen Products LP |
59676-701, 59676-702 |
| Cabotegravir and Rilpivirine | Makes the active ingredient and tests it |
ViiV Healthcare Company |
49702-240, 49702-253 |
| Canagliflozin | Makes the active ingredient |
Janssen Pharmaceuticals, Inc. |
50458-140, 50458-141 |
| Canagliflozin and Metformin | Makes the active ingredient and tests it |
Janssen Pharmaceuticals, Inc. |
50458-540, 50458-541, 50458-542 +5 |
| Darunavir | Makes the active ingredient |
Janssen Products LP |
59676-565 |
| Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide | Makes it |
Janssen Products LP |
59676-800 |
| Esketamine | Makes the active ingredient |
Janssen Pharmaceuticals, Inc. |
50458-028 |
| Etravirine | Makes the active ingredient and tests it |
Janssen Products LP, Patriot Pharmaceuticals |
59676-570, 59676-571, 59676-572 +2 |
| Haloperidol | Makes the active ingredient |
Janssen Pharmaceuticals, Inc., Patriot Pharmaceuticals |
50458-253, 50458-254, 10147-0921 +1 |
| Icotrokinra | Makes the active ingredient and tests it |
Janssen Biotech, Inc. |
57894-201 |
| Itraconazole | Makes the active ingredient |
Janssen Pharmaceuticals, Inc., Patriot Pharmaceuticals |
50458-290, 10147-1700 |
| Lazertinib | Makes it, makes the active ingredient and tests it |
Janssen Biotech, Inc. |
57894-080, 57894-240 |
| Rilpivirine | Makes the active ingredient |
Janssen Products LP |
59676-278, 59676-280 |
| Risperidone | Makes the active ingredient |
Janssen Pharmaceuticals, Inc. |
50458-305, 50458-596 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| Mar 26, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 27, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 4, 2015 | No problems found | Drug Quality Assurance | — |
| Sep 12, 2013 | No problems found | Drug Quality Assurance | — |
| Oct 18, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 6, 2011 | No problems found | Drug Quality Assurance | — |
| Dec 10, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture.