Drug factory · FDA FEI 3002807691

Institut National des Radio-Elements

Avenue de l'Espérance 1, Fleurus, Belgium

Belgium: 1

Problems found, fixed voluntarily at FDA's last inspection, Oct 8, 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 2017: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Technetium Tc-99m PertechnetateMakes the active ingredient Lantheus Medical Imaging, Inc., Shine Spect USA, LLC 11994-090, 11994-091, 87333-090 +1
Xenon Xe-133Makes the active ingredient Lantheus Medical Imaging, Inc., Shine Spect USA, LLC 11994-127, 11994-128, 87333-127 +1

FDA inspection history

EndedResultProgramProblems noted
Oct 8, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 8, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 14, 2017Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: api manufacture.