Drug factory · FDA FEI 3008093605

Minakem Dunkerque Production

Zone D Entreprises Du Nord Gracht 224 Avenue De La Dordogne, Dunkerque, France

France: 1

Problems found, fixed voluntarily at FDA's last inspection, May 21, 2021.

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 2013: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
BudesonideMakes the active ingredient Calliditas Therapeutics AB 81749-004
MetyraponeTests it Esteve Pharmaceuticals, S.a., HRA Pharma Rare Diseases 68118-455, 76336-455

FDA inspection history

EndedResultProgramProblems noted
May 21, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 22, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 22, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
May 17, 2013No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.