Drug factory · FDA FEI 3002807003
Astellas Pharma Inc.
2-178, Kojinmachi, Toyama, Japan
No problems found at FDA's last inspection, Apr 18, 2024.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2008: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Tacrolimus | Makes it, makes the active ingredient and tests it | Astellas Pharma US, Inc. | 0469-0647, 0469-0677, 0469-0687 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 18, 2024 | No problems found | Drug Quality Assurance | — |
| May 31, 2019 | No problems found | Drug Quality Assurance | — |
| Nov 11, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 25, 2014 | No problems found | Drug Quality Assurance | — |
| Feb 10, 2012 | No problems found | Drug Quality Assurance | — |
| Oct 31, 2008 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture.