Drug factory · FDA FEI 3002807802

Ajinomoto Omnichem

Cooppallaan 91, Wetteren, Belgium

Belgium: 1

Problems found, fixed voluntarily at FDA's last inspection, Jun 13, 2025.

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

5 drug inspections on record since 2009: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AbirateroneMakes the active ingredient Janssen Biotech, Inc. 57894-150, 57894-195
BrigatinibMakes the active ingredient and tests it Takeda Pharmaceuticals America, Inc. 63020-090, 63020-113, 63020-180 +1
CanagliflozinMakes the active ingredient Janssen Pharmaceuticals, Inc. 50458-140, 50458-141
Canagliflozin and MetforminMakes the active ingredient Janssen Pharmaceuticals, Inc. 50458-540, 50458-541, 50458-542 +1
MaribavirMakes the active ingredient and tests it Takeda Pharmaceuticals America, Inc. 64764-800
QuetiapineMakes the active ingredient H2-Pharma LLC 61269-250, 61269-251, 61269-252 +8

FDA inspection history

EndedResultProgramProblems noted
Jun 13, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 16, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 22, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 24, 2014No problems foundDrug Quality Assurance—
Dec 4, 2009Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.