Drug factory · FDA FEI 2211100
Janssen Pharmaceuticals Inc.
1000 Route 202 South, Raritan, NJ, United States
No problems found at FDA's last inspection, Jun 17, 2022.
No Action Indicated: inspectors found no objectionable conditions.
8 drug inspections on record since 2009: 7 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ciltacabtagene Autoleucel | Makes it and tests it | Janssen Biotech, Inc. | 57894-111 |
| Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide | Tests it | Janssen Products LP | 59676-800 |
| Esketamine | Tests it | Janssen Pharmaceuticals, Inc. | 50458-028 |
| Methylphenidate | Tests it | Janssen Pharmaceuticals, Inc. | 50458-585, 50458-586, 50458-587 +1 |
| Rivaroxaban | Tests it | Janssen Pharmaceuticals, Inc. | 50458-575 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 17, 2022 | No problems found | Drug Quality Assurance | — |
| Jan 26, 2017 | No problems found | Drug Quality Assurance | — |
| Jan 22, 2016 | No problems found | Bioresearch Monitoring | — |
| May 21, 2013 | No problems found | Bioresearch Monitoring | — |
| Jun 19, 2012 | No problems found | Drug Quality Assurance | — |
| Aug 22, 2011 | No problems found | Drug Quality Assurance | — |
| Aug 6, 2010 | No problems found | Drug Quality Assurance | — |
| Jan 15, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.