Drug factory · FDA FEI 3003382089

Upjohn Manufacturing Ireland Unlimited Company

Little Island, Cork, Ireland

Ireland: 1

Problems found, fixed voluntarily at FDA's last inspection, Jan 26, 2024.

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 2011: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AxitinibMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-0145, 0069-0151
CrizotinibMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-0251, 0069-0507, 0069-1500 +2
VoriconazoleMakes the active ingredient Mylan Pharmaceuticals Inc., Roerig 59762-0935, 0049-3160, 0049-3170 +3

FDA inspection history

EndedResultProgramProblems noted
Jan 26, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 2, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Aug 31, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 25, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 11, 2014No problems foundDrug Quality Assurance—
Jun 17, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.