Drug factory · FDA FEI 3002808179

Xellia Pharmaceuticals Ltd.

Szállás utca 1-3, Budapest, Hungary

Hungary: 1

Problems found, fixed voluntarily at FDA's last inspection, Jul 30, 2025.

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

4 drug inspections on record since 2011: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
VancomycinTests it Xellia Pharmaceuticals USA LLC 70594-045, 70594-046

FDA inspection history

EndedResultProgramProblems noted
Jul 30, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 8, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 5, 2014No problems foundDrug Quality Assurance—
Jun 24, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.