Drug factory · FDA FEI 3002807307

Istituto Di Ricerche Biomediche Antoine Marxer RBM SpA

VIA RIBES, 1, Colleretto Giacosa, Italy

Italy: 1

Problems found, fixed voluntarily at FDA's last inspection, Jul 12, 2024.

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

5 drug inspections on record since 2011: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
PegfilgrastimTests it Fresenius Kabi USA, LLC, Northstar Rx LLC. 65219-371, 72603-402

FDA inspection history

EndedResultProgramProblems noted
Jul 12, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 30, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 4, 2017No problems foundDrug Quality Assurance—
Jul 4, 2014No problems foundDrug Quality Assurance—
Jun 24, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis.