Drug factory · FDA FEI 3002807496

LEO Pharma A/S

Industriparken 55, Ballerup, Denmark

Denmark: 1

Problems found, fixed voluntarily at FDA's last inspection, Sep 26, 2024.

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

6 drug inspections on record since 2009: 0 with no problems, 5 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

DrugRoleForNDC
TralokinumabMakes it LEO Pharma Inc. 50222-346, 50222-350

FDA inspection history

EndedResultProgramProblems noted
Sep 26, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 17, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 21, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 15, 2011Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 15, 2011Problems found, fixed voluntarilyBioresearch Monitoring—
Jun 16, 2009Serious problems, FDA actionDrug Quality Assurance—

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