Drug factory · FDA FEI 1033845
Janssen Pharmaceuticals, Inc.
1440 Olympic Drive, Athens, GA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 24, 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: 4 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Apalutamide | Makes the active ingredient, tests it and packages it | Janssen Products LP | 59676-600, 59676-604 |
| Esketamine | Makes the active ingredient | Janssen Pharmaceuticals, Inc. | 50458-028 |
| Methylphenidate | Makes the active ingredient | Aurolife Pharma LLC, Janssen Pharmaceuticals, Inc. | 13107-380, 13107-381, 13107-382 +4 |
| Tapentadol | Makes the active ingredient | Collegium Pharmaceutical, Inc., Depo NF Sub, LLC | 24510-050, 24510-058, 24510-075 +13 |
| Topiramate | Makes the active ingredient | Janssen Pharmaceuticals, Inc. | 50458-639, 50458-640, 50458-641 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 24, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 14, 2017 | No problems found | Drug Quality Assurance | — |
| Feb 20, 2014 | No problems found | Drug Quality Assurance | — |
| Feb 18, 2011 | No problems found | Drug Quality Assurance | — |
| Mar 27, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; pack.