Drug factory · FDA FEI 3002958688

Enestia Belgium NV

Klocknerstraat 1, Hamont-Achel, Belgium

Belgium: 1

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

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

3 drug inspections on record since 2016: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
CaplacizumabPackages it and labels it Genzyme Corporation 58468-0225

FDA inspection history

EndedResultProgramProblems noted
Dec 13, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 15, 2017No problems foundDrug Quality Assurance—
Mar 11, 2016Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: label; pack.