Drug factory · FDA FEI 3008676264

PPD Development Ireland Ltd.

Building C, Ida Business and Technology Park, Garrycastle, Athlone, Ireland

Ireland: 1

Problems found, fixed voluntarily at FDA's last inspection, Mar 9, 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 2011: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AlirocumabTests it Regeneron Pharmaceuticals, Inc. 61755-020, 61755-021
AmikacinTests it Insmed Incorporated 71558-590
DaratumumabTests it Janssen Biotech, Inc. 57894-502
Efanesoctocog AlfaTests it Bioverativ Therapeutics Inc. 71104-978, 71104-979, 71104-981 +3
Efmoroctocog AlfaTests it Bioverativ Therapeutics Inc. 71104-801, 71104-802, 71104-803 +7
Eftrenonacog AlfaTests it Bioverativ Therapeutics Inc. 71104-911, 71104-922, 71104-933 +3
FitusiranTests it Genzyme Corporation 58468-0347, 58468-0348
GuselkumabTests it Janssen Biotech, Inc. 57894-640, 57894-651
UstekinumabTests it Janssen Biotech, Inc. 57894-054, 57894-444

FDA inspection history

EndedResultProgramProblems noted
Mar 9, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 19, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 22, 2016No problems foundDrug Quality Assurance—
Nov 9, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis.