Drug factory · FDA FEI 3003637173

Pfizer Italia S.r.l.

Localita Marino Del Tronto, Ascoli Piceno, Italy

Italy: 1

Problems found, fixed voluntarily at FDA's last inspection, Mar 14, 2025.

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 2010: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
CabergolineMakes it, tests it, packages it and labels it Mylan Pharmaceuticals Inc. 59762-1005
DofetilideMakes it, tests it and packages it Pfizer Laboratories Div Pfizer Inc 0069-5800, 0069-5810, 0069-5820
Estrogens, ConjugatedPackages it and labels it Prasco Laboratories, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 66993-295, 66993-296, 66993-297 +7
Estrogens, Conjugated and MedroxyprogesteronePackages it and labels it Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0046-1105, 0046-1106, 0046-1107 +1
ExemestaneMakes it, tests it, packages it and labels it Mylan Pharmaceuticals Inc., Pharmacia & Upjohn Company LLC 59762-2858, 0009-7663
MedroxyprogesteroneMakes it, tests it, packages it and labels it Mylan Pharmaceuticals Inc., Pharmacia & Upjohn Company LLC 59762-0055, 59762-0056, 59762-0058 +3
MethylprednisoloneMakes it, tests it, packages it and labels it Mylan Pharmaceuticals Inc., Pharmacia & Upjohn Company LLC 59762-0049, 59762-0050, 59762-0051 +7
Nirmatrelvir and RitonavirMakes it, tests it, packages it and labels it Pfizer Laboratories Div Pfizer Inc 0069-5045, 0069-5317, 0069-5321 +2
PhenytoinTests it Parke-Davis Div of Pfizer Inc, Prasco Laboratories 0071-0007, 66993-372
RifabutinMakes it, tests it, packages it and labels it Mylan Pharmaceuticals Inc., Pfizer Laboratories Div Pfizer Inc 59762-1350, 0013-5301
SunitinibMakes it, tests it, packages it and labels it Pfizer Laboratories Div Pfizer Inc 0069-0550, 0069-0770, 0069-0830 +1
TriazolamMakes it, tests it, packages it and labels it Mylan Pharmaceuticals Inc. 59762-3717, 59762-3718
VareniclineMakes it, tests it, packages it and labels it Pfizer Laboratories Div Pfizer Inc 0069-0468, 0069-0469, 0069-0471
VoriconazoleMakes it, tests it, packages it and labels it Mylan Pharmaceuticals Inc., Roerig 59762-0935, 0049-3170, 0049-3180

FDA inspection history

EndedResultProgramProblems noted
Mar 14, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 30, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 9, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 22, 2013No problems foundDrug Quality Assurance—
Nov 11, 2010No problems foundDrug Quality Assurance—

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