Drug factory · FDA FEI 3002808534

Yuki Gosei Kogyo Co., Ltd.

OCHIAI788, JOBANNISHIGOMACHI, Iwaki, Japan

Japan: 1

Problems found, fixed voluntarily at FDA's last inspection, Feb 6, 2026.

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

7 drug inspections on record since 2010: 1 with no problems, 4 with problems fixed voluntarily, 2 with FDA action.

What it does, for whom

DrugRoleForNDC
IsoniazidMakes the active ingredient CMP Pharma, Inc. 46287-009
Tipiracil and TrifluridineMakes the active ingredient Taiho Pharmaceutical Co., Ltd. 64842-1020, 64842-1025

FDA inspection history

EndedResultProgramProblems noted
Feb 6, 2026Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 28, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 17, 2017Serious problems, FDA actionDrug Quality Assurance—
Sep 2, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 7, 2014No problems foundDrug Quality Assurance—
Jun 22, 2012Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 21, 2010Serious problems, FDA actionDrug Quality Assurance—

Registered with FDA for: api manufacture.