Drug factory · FDA FEI 3002807473

Astrea Fontaine

Site de Fontaine Rue Des Pres Potets, Fontaine Les Dijon, France

France: 1

Problems found, fixed voluntarily at FDA's last inspection, Sep 13, 2024.

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 2016: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
PacritinibMakes it, tests it, packages it and labels it Sobi, Inc. 72482-100
TetrabenazineMakes it, packages it and labels it Lundbeck Pharmaceuticals LLC, Oceanside Pharmaceuticals. 67386-421, 67386-422, 68682-421 +1

FDA inspection history

EndedResultProgramProblems noted
Sep 13, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 11, 2020Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 10, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 22, 2016Problems found, fixed voluntarilyDrug Quality Assurance—

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