Drug factory · FDA FEI 3007075468
Eirgen Pharma Ltd
Waterford Business Park, Waterford, Ireland
Problems found, fixed voluntarily at FDA's last inspection, Oct 13, 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 2010: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Etoposide | Makes it, tests it, packages it and labels it | Onesource Specialty Pharma Limited | 83270-451 |
| Exemestane | Makes it and packages it | Eirgen Pharma Ltd | 44278-025 |
| Toremifene | Makes it | Rising Pharma Holdings, Inc. | 64980-404 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 13, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 9, 2018 | No problems found | Drug Quality Assurance | — |
| Aug 15, 2014 | No problems found | Drug Quality Assurance | — |
| Sep 14, 2012 | No problems found | Drug Quality Assurance | — |
| Sep 21, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; relabel; repack.