Drug factory · FDA FEI 3002807361
Janssen Pharmaceutical Sciences Unlimited Company
LITTLE ISLAND INDUSTRIAL ESTATE T45 P663, Co Cork, Ireland
Problems found, fixed voluntarily at FDA's last inspection, Oct 27, 2023.
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 |
|---|---|---|---|
| Cobicistat and Darunavir | Makes the active ingredient | Janssen Products LP | 59676-575, 59676-577, 59676-578 |
| Darunavir | Makes the active ingredient | Janssen Products LP | 59676-562, 59676-563, 59676-564 +2 |
| Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide | Makes the active ingredient and tests it | Janssen Products LP | 59676-800 |
| Itraconazole | Makes the active ingredient | Janssen Pharmaceuticals, Inc., Patriot Pharmaceuticals | 50458-290, 10147-1700 |
| Paliperidone | Makes the active ingredient | Janssen Pharmaceuticals, Inc. | 50458-550, 50458-551, 50458-552 +10 |
| Rilpivirine | Makes the active ingredient | Janssen Products LP | 59676-278, 59676-280 |
| Risperidone | Makes the active ingredient and tests it | Janssen Pharmaceuticals, Inc. | 50458-300, 50458-302, 50458-305 +18 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 27, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 9, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 24, 2017 | No problems found | Drug Quality Assurance | — |
| Mar 21, 2014 | No problems found | Drug Quality Assurance | — |
| Apr 21, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.