Drug factory · FDA FEI 3004186644

SGS Lab Simon

Vieux Chemin du Poete 10, Wavre (Bierges), Belgium

Belgium: 1

Problems found, fixed voluntarily at FDA's last inspection, Mar 10, 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 2012: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
.alpha.1-Proteinase Inhibitor HumanTests it Takeda Pharmaceuticals America, Inc. 0944-2884
Apadamtase AlfaTests it Takeda Pharmaceuticals America, Inc. 64764-140, 64764-145

FDA inspection history

EndedResultProgramProblems noted
Mar 10, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 22, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 27, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 6, 2014No problems foundDrug Quality Assurance—
Jun 20, 2012No problems foundDrug Quality Assurance—

Registered with FDA for: analysis.