Drug factory · FDA FEI 3002807852

Pfizer Ireland Pharmaceuticals Unlimited Company

RINGASKIDDY API PLANT, Ringaskiddy, Ireland

Ireland: 1

Problems found, fixed voluntarily at FDA's last inspection, Oct 25, 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
AbrocitinibMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticals 0069-0235, 0069-0335, 0069-0435 +3
Amlodipine and AtorvastatinMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc, Prasco Laboratories, Viatris Specialty LLC 0069-2150, 0069-2160, 0069-2170 +32
AxitinibMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-0145, 0069-0151
AzithromycinMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-0400, 0069-3051, 0069-3060 +8
BosutinibMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticals 0069-0135, 0069-0136, 0069-0193 +4
CrisaboroleMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 55724-211
CrizotinibMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-0251, 0069-0507, 0069-1500 +2
DacomitinibMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-0197, 0069-1198, 0069-2299
DesvenlafaxineMakes the active ingredient and tests it Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0008-1210, 0008-1211, 0008-1222
DofetilideMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-5800, 0069-5810, 0069-5820
EtrasimodMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-0274
FesoterodineMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-0242, 0069-0244
FluconazoleMakes the active ingredient and tests it Mylan Pharmaceuticals Inc., Roerig 59762-5015, 59762-5016, 59762-5017 +9
GlasdegibMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-0298, 0069-1531
LorlatinibMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticals 0069-0227, 0069-0231, 63539-927
Nirmatrelvir and RitonavirMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-0521, 0069-5045, 0069-5317 +3
PalbociclibMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticals 0069-0187, 0069-0188, 0069-0189 +6
PrazosinMakes the active ingredient and tests it Prasco Laboratories 66993-431, 66993-432, 66993-433
RitlecitinibMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticals 0069-0334, 63539-334
SunitinibMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-0550, 0069-0770, 0069-0830 +1
TafamidisMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-1975, 0069-8730
TalazoparibMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-0252, 0069-0353, 0069-0454 +3
TemsirolimusMakes the active ingredient and tests it Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0008-1179
TigecyclineMakes the active ingredient and tests it Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0008-4990, 0008-4994
TofacitinibMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticals 0069-0501, 0069-0502, 0069-1001 +7
VareniclineMakes the active ingredient and tests it Pfizer Laboratories Div Pfizer Inc 0069-0468, 0069-0469, 0069-0471
VoriconazoleMakes the active ingredient and tests it Mylan Pharmaceuticals Inc., Roerig 59762-0935, 0049-3160, 0049-3170 +3

FDA inspection history

EndedResultProgramProblems noted
Oct 25, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Aug 17, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 26, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 29, 2016No problems foundDrug Quality Assurance—
Aug 1, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 24, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.