Drug factory · FDA FEI 3002809479

NUVISAN GmbH

Wegenerstrasse 13, Neu-Ulm, Germany

Germany: 1

Problems found, fixed voluntarily at FDA's last inspection, Oct 17, 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 2012: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Birch TriterpenesTests it Amryt Pharmaceuticals Designated Activity Company, Chiesi USA, Inc. 76431-310, 10122-310

FDA inspection history

EndedResultProgramProblems noted
Oct 17, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 6, 2020Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 8, 2018Problems found, fixed voluntarilyBioresearch Monitoring—
Jul 25, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
May 16, 2012No problems foundDrug Quality Assurance—

Registered with FDA for: analysis.