Drug factory · FDA FEI 3003677791

Ajinomoto Omnichem

Japanse-Kerselarenlaan 1, Balen, Belgium

Belgium: 1

Problems found, fixed voluntarily at FDA's last inspection, Jun 24, 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 2011: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
RufinamideMakes the active ingredient Eisai Inc. 62856-582, 62856-583, 62856-584

FDA inspection history

EndedResultProgramProblems noted
Jun 24, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 16, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 29, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 20, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 10, 2011No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.