Drug factory · FDA FEI 3003808559

Otsuka Pharmaceutical Co., Ltd.

AZAHIGASHIYAMA5006-5, OMAGARI, YOSHINOGARICHO, Kanzaki-gun, Japan

Japan: 1

Problems found, fixed voluntarily at FDA's last inspection, Jul 11, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

6 drug inspections on record since 2011: 0 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
TolvaptanMakes the active ingredient and tests it Otsuka America Pharmaceutical, Inc. 59148-079, 59148-080, 59148-082 +4

FDA inspection history

EndedResultProgramProblems noted
Jul 11, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 1, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 8, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 5, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 25, 2012Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 14, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.