Drug factory · FDA FEI 3002808410

Polypeptide

Chaussee de Tubize 297, Braine-I'Alleud, Belgium

Belgium: 1

Problems found, fixed voluntarily at FDA's last inspection, Dec 18, 2023.

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

What it does, for whom

DrugRoleForNDC
AbaloparatideMakes the active ingredient Radius Health, Inc. 70539-001

FDA inspection history

EndedResultProgramProblems noted
Dec 18, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 2, 2020Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 16, 2017No problems foundDrug Quality Assurance—
May 30, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 14, 2012No problems foundDrug Quality Assurance—
Jun 16, 2009No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.