Drug factory · FDA FEI 3003323169

Kaneka Eurogentec SA

Rue du Bois Saint-Jean 14, Seraing, Belgium

Belgium: 1

Problems found, fixed voluntarily at FDA's last inspection, Feb 26, 2024.

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
GlucarpidaseMakes the active ingredient BTG International Inc. 50633-210

FDA inspection history

EndedResultProgramProblems noted
Feb 26, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 6, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 27, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 19, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 28, 2013Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 27, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.