Drug factory · FDA FEI 3005403283
Astellas Ireland Co., Limited
DAMASTOWN ROAD, Dublin, Ireland
Problems found, fixed voluntarily at FDA's last inspection, Jun 17, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2013: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Mirabegron | Makes the active ingredient and tests it | Astellas Pharma US, Inc. | 0469-2601, 0469-2602, 0469-5020 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 17, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 17, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 12, 2016 | No problems found | Drug Quality Assurance | — |
| Sep 19, 2013 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.