Drug factory · FDA FEI 3007029098

Janssen Sciences Ireland UC

Barnahely Ringaskiddy, CO Cork, Ireland

Ireland: 1

Problems found, fixed voluntarily at FDA's last inspection, Jan 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 2012: 0 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AmivantamabMakes the active ingredient and tests it Janssen Biotech, Inc. 57894-501
Amivantamab and Hyaluronidase (human Recombinant)Makes the active ingredient and tests it Janssen Biotech, Inc. 57894-510, 57894-514, 57894-515 +1
DaratumumabTests it Janssen Biotech, Inc. 57894-502, 57894-505
Daratumumab and Hyaluronidase (human Recombinant)Tests it Janssen Biotech, Inc. 57894-503
GolimumabMakes the active ingredient and tests it Janssen Biotech, Inc. 57894-070, 57894-071, 57894-350
GuselkumabMakes the active ingredient and tests it Janssen Biotech, Inc. 57894-640, 57894-650, 57894-651
NipocalimabMakes the active ingredient and tests it Janssen Biotech, Inc. 57894-800, 57894-801
SiltuximabTests it Recordati Rare Diseases, Inc. 73090-420
TalquetamabMakes the active ingredient and tests it Janssen Biotech, Inc. 57894-469, 57894-470
TeclistamabMakes the active ingredient and tests it Janssen Biotech, Inc. 57894-449, 57894-450
UstekinumabMakes the active ingredient and tests it Janssen Biotech, Inc. 57894-054, 57894-060, 57894-061 +3

FDA inspection history

EndedResultProgramProblems noted
Jan 12, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 20, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 3, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 7, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 18, 2012Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.