Drug factory · FDA FEI 2242843
Janssen Pharmaceuticals, Inc.
PO Box 200 1125 Trenton Harbourton Rd, Titusville, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 25, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
11 drug inspections on record since 2009: 8 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Canagliflozin | Tests it | Janssen Pharmaceuticals, Inc. | 50458-140, 50458-141 |
| Canagliflozin and Metformin | Tests it | Janssen Pharmaceuticals, Inc. | 50458-540, 50458-541, 50458-542 +5 |
| Darunavir | Tests it | Janssen Products LP | 59676-562, 59676-563, 59676-564 +2 |
| Etravirine | Tests it | Janssen Products LP, Patriot Pharmaceuticals | 59676-570, 59676-571, 59676-572 +2 |
| Methylphenidate | Tests it | Janssen Pharmaceuticals, Inc. | 50458-585, 50458-586, 50458-587 +1 |
| Paliperidone | Tests it | Janssen Pharmaceuticals, Inc. | 50458-606, 50458-607, 50458-608 +3 |
| Rivaroxaban | Tests it | Janssen Pharmaceuticals, Inc. | 50458-575 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 25, 2026 | Problems found, fixed voluntarily | Bioresearch Monitoring | 1 |
| Aug 14, 2025 | No problems found | Drug Quality Assurance | — |
| Sep 27, 2024 | Problems found, fixed voluntarily | Bioresearch Monitoring | 2 |
| Sep 27, 2024 | Problems found, fixed voluntarily | Bioresearch Monitoring | 2 |
| Sep 28, 2020 | No problems found | Bioresearch Monitoring | — |
| Sep 14, 2020 | No problems found | Drug Quality Assurance | — |
| Apr 22, 2015 | No problems found | Drug Quality Assurance | — |
| Dec 12, 2013 | No problems found | Bioresearch Monitoring | — |
| Jun 28, 2012 | No problems found | Drug Quality Assurance | — |
| Jun 1, 2011 | No problems found | Drug Quality Assurance | — |
| Apr 9, 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.
Sep 25, 2026 inspection
- Failure to comply with REMS Elements to Assure Safe Use (ETASU) D FDCA 505-1(f)(3)(D)
An application holder did not ensure each patient receiving the drug has evidence or other documentation of safe-use conditions, as required by your approved REMS Element to Assure Safe Use (ETASU) D.
Sep 27, 2024 inspection
- Failure to comply with REMS Implementation System FDCA 505-1(f)(4)
An application holder did not comply with the audit plan and schedule described in the REMS, as required by your approved REMS Implementation System. - Failure to comply with REMS Implementation System FDCA 505-1(f)(4)
An application holder did not comply with the audit plan and schedule described in the REMS, as required by your approved REMS Implementation System.
Registered with FDA for: analysis.