Drug factory · FDA FEI 3003744181

Gentium S.r.L

Piazza XX Settembre, 2, Villa Guardia, Italy

Italy: 1

Problems found, fixed voluntarily at FDA's last inspection, Dec 17, 2021.

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

3 drug inspections on record since 2015: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Defibrotide Free AcidMakes the active ingredient and tests it Jazz Pharmaceuticals, Inc. 68727-800

FDA inspection history

EndedResultProgramProblems noted
Dec 17, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 15, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 4, 2015No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.