Drug factory · FDA FEI 3002807020
Astellas Ireland Co., Ltd.
Bansha, Killorglin, Ireland
Problems found, fixed voluntarily at FDA's last inspection, Sep 2, 2022.
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 2013: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Tacrolimus | Makes it and tests it | Astellas Pharma US, Inc. | 0469-0647, 0469-0677, 0469-0687 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 2, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 8, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 23, 2017 | No problems found | Drug Quality Assurance | — |
| Nov 21, 2014 | No problems found | Drug Quality Assurance | — |
| Mar 8, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture; pack.