Drug factory · FDA FEI 3003128853

Kyowa Pharma Chemical Co., Ltd.

530 Chokeiji, Takaoka, Japan

Japan: 1

Problems found, fixed voluntarily at FDA's last inspection, Dec 9, 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 2011: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
DinoprostoneMakes the active ingredient Ferring Pharmaceuticals Inc. 55566-2800
OlopatadineMakes the active ingredient Sandoz Inc. 61314-320

FDA inspection history

EndedResultProgramProblems noted
Dec 9, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 20, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Aug 28, 2014No problems foundDrug Quality Assurance—
Mar 3, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture; label; pack.