Drug factory · FDA FEI 3002808523

Astellas Pharma Inc.

160-2, Akahama, Takahagi, Japan

Japan: 1

Problems found, fixed voluntarily at FDA's last inspection, Jun 6, 2025.

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 2009: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
MirabegronMakes the active ingredient and tests it Astellas Pharma US, Inc. 0469-2601, 0469-2602, 0469-5020

FDA inspection history

EndedResultProgramProblems noted
Jun 6, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 13, 2018No problems foundDrug Quality Assurance—
Jun 27, 2014No problems foundDrug Quality Assurance—
Oct 15, 2009Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.