Drug factory · FDA FEI 3003724414

Helsinn Birex Pharmaceuticals Limited

Damastown Way Dublin 15, Dublin, Ireland

Ireland: 1

Problems found, fixed voluntarily at FDA's last inspection, Jul 15, 2022.

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 2010: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Fosnetupitant and PalonosetronMakes it, tests it and labels it Helsinn Therapeutics (U.S.), Inc. 69639-102, 69639-105, 69639-106
Netupitant and PalonosetronMakes it and labels it Helsinn Therapeutics (U.S.), Inc. 69639-101
PalonosetronPackages it Cipla USA., Inc. 69097-927

FDA inspection history

EndedResultProgramProblems noted
Jul 15, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 25, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 22, 2017No problems foundDrug Quality Assurance—
Jun 3, 2016No problems foundDrug Quality Assurance—
Feb 21, 2014No problems foundDrug Quality Assurance—
May 27, 2010Problems found, fixed voluntarilyDrug Quality Assurance—

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