Drug factory · FDA FEI 3002717526

Bioindustria Laboratorio Italiano Medicinali S.p.A

Via De Ambrosiis, 2-4-6, Novi Ligure, Italy

Italy: 1

Problems found, fixed voluntarily at FDA's last inspection, Jul 25, 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 2013: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Ethacrynic AcidMakes it and tests it Leading Pharma, LLC 69315-701
Mycophenolic AcidMakes it and tests it BPI Labs, LLC 54288-141

FDA inspection history

EndedResultProgramProblems noted
Jul 25, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 24, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 15, 2018No problems foundDrug Quality Assurance—
Mar 10, 2015Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 25, 2013Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; manufacture.