Drug factory · FDA FEI 3002809620
Astellas Pharma Inc.
180, Ozumi, Yaizu, Japan
Problems found, fixed voluntarily at FDA's last inspection, Oct 27, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2016: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fezolinetant | Makes it and tests it | Astellas Pharma US, Inc. | 0469-2460, 0469-2660, 0469-2760 |
| Mirabegron | Makes it and tests it | Astellas Pharma US, Inc. | 0469-5020 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 27, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Mar 7, 2016 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 27, 2023 inspection
- Complaint Investigation/Follow-Up Findings 21 CFR 211.198(b)(2)
Complaint records are deficient in that they do not include the findings of the.
Registered with FDA for: analysis; manufacture.