Drug factory · FDA FEI 1000170338
Thermo Fisher Scientific Cork Limited
Currabinny, Carrigaline, Ireland
Problems found, fixed voluntarily at FDA's last inspection, Sep 7, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2009: 1 with no problems, 4 with problems fixed voluntarily, 1 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 +1 |
| Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide | Makes the active ingredient | Janssen Products LP | 59676-800 |
| Tapinarof | Makes the active ingredient and tests it | Organon LLC | 81672-5051 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 7, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 26, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 26, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 1, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 23, 2013 | Serious problems, FDA action | Drug Quality Assurance | — |
| Sep 10, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.