Drug factory · FDA FEI 3002808260

Leo Pharma Manufacturing Italy SRL.

VIA Ernest Schering 21, Segrate, Italy

Italy: 1

Problems found, fixed voluntarily at FDA's last inspection, Nov 30, 2023.

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 2012: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Azelaic AcidMakes it Sandoz Inc. 0781-7172

FDA inspection history

EndedResultProgramProblems noted
Nov 30, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 25, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 11, 2014No problems foundDrug Quality Assurance—
Mar 28, 2012No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; label; manufacture; pack.