Drug factory · FDA FEI 3002807165

R-Pharm Germany GmbH

Heinrich-Mack-Str. 35, Illertissen, Germany

Germany: 1

Problems found, fixed voluntarily at FDA's last inspection, Feb 28, 2023.

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 2010: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
CladribinePackages it and labels it EMD Serono, Inc. 44087-4000

FDA inspection history

EndedResultProgramProblems noted
Feb 28, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Aug 1, 2019No problems foundDrug Quality Assurance—
Nov 7, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 18, 2010No problems foundDrug Quality Assurance—

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