Drug factory · FDA FEI 3006785053
Pfizer Ireland Pharmaceuticals Unlimited Company
Little Connell, Newbridge, Ireland
Problems found, fixed voluntarily at FDA's last inspection, Sep 23, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2009: 3 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Bazedoxifene and Estrogens, Conjugated | Makes it, tests it, packages it and labels it |
U.S. Pharmaceuticals, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
63539-122, 0008-1123 |
| Desvenlafaxine | Makes it, tests it, packages it and labels it |
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
0008-1210, 0008-1211, 0008-1222 |
| Estrogens, Conjugated | Makes it, makes the active ingredient, tests it and packages it |
Prasco Laboratories, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
66993-295, 66993-296, 66993-297 +9 |
| Estrogens, Conjugated and Medroxyprogesterone | Makes it and tests it |
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
0046-1105, 0046-1106, 0046-1107 +2 |
| Nirmatrelvir and Ritonavir | Makes it, tests it, packages it and labels it |
Pfizer Laboratories Div Pfizer Inc |
0069-0521, 0069-5045, 0069-5317 +3 |
| Sirolimus | Makes it and tests it |
Mylan Pharmaceuticals Inc. |
59762-1001, 59762-1002, 59762-1003 |
| Temsirolimus | Tests it |
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
0008-1179 |
| Tofacitinib | Makes it and tests it |
Pfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticals |
0069-0501, 63539-501 |
| Triazolam | Makes it and tests it |
Mylan Pharmaceuticals Inc. |
59762-3717, 59762-3718 |
| Varenicline | Tests it |
Pfizer Laboratories Div Pfizer Inc |
0069-0468, 0069-0469, 0069-0471 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| Sep 23, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 27, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 13, 2018 | No problems found | Drug Quality Assurance | — |
| Jul 29, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 12, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 8, 2013 | No problems found | Drug Quality Assurance | — |
| Oct 24, 2011 | No problems found | Drug Quality Assurance | — |
| Aug 20, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.