Drug factory · FDA FEI 3004145594
Pfizer Ireland Pharmaceuticals Unlimited Company
Grange Castle Business Park, Nangor Road, Dublin, Ireland
Problems found, fixed voluntarily at FDA's last inspection, Dec 15, 2023.
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 2009: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Adalimumab | Tests it |
Pfizer Laboratories Div Pfizer Inc |
0025-0319 |
| Adalimumab and Isopropyl Alcohol | Tests it |
Pfizer Laboratories Div Pfizer Inc |
0025-0325, 0025-0328, 0025-0333 +1 |
| Bevacizumab | Tests it |
Pfizer Laboratories Div Pfizer Inc |
0069-0315, 0069-0342 |
| Bnt-162b2 Omicron (xfg) Mrna | Makes the active ingredient and tests it |
Pfizer Laboratories Div Pfizer Inc |
0069-2609, 0069-2631 |
| Bnt162b2 Omicron (lp.8.1) | Makes the active ingredient and tests it |
Pfizer Laboratories Div Pfizer Inc |
0069-2501, 0069-2528 |
| Isopropyl Alcohol and Moroctocog Alfa | Makes the active ingredient and tests it |
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC |
58394-012, 58394-013, 58394-014 +6 |
| Marstacimab | Tests it |
Pfizer Laboratories Div Pfizer Inc |
0069-0775, 0069-1510, 0069-1575 +1 |
| Meningococcal Groups A, B, C, W, and Y Vaccine | Makes it, makes the active ingredient and tests it |
Pfizer Laboratories Div Pfizer Inc |
0069-0600 |
| Neisseria Meningitidis Group B Recombinant Lp2086 A05 Protein Variant Antigen and Neisseria Meningitidis Group B Recombinant Lp2086 B01 Protein Variant Antigen | Makes it, makes the active ingredient and tests it |
Wyeth Pharmaceutical Division of Wyeth Holdings LLC |
0005-0100 |
| Pegvisomant | Makes the active ingredient and tests it |
Pharmacia & Upjohn Company LLC |
0009-7166, 0009-7168, 0009-7188 +2 |
| Pneumococcal 20-Valent Conjugate Vaccine | Makes it, makes the active ingredient, tests it and packages it |
Wyeth Pharmaceutical Division of Wyeth Holdings LLC |
0005-2000 |
| Recombinant Stabilized Rsv A Prefusion F Antigen and Recombinant Stabilized Rsv B Prefusion F Antigen | Tests it |
Pfizer Laboratories Div Pfizer Inc |
0069-0344, 0069-2465 |
| Rituximab | Makes the active ingredient and tests it |
Pfizer Laboratories Div Pfizer Inc |
0069-0238, 0069-0249 |
| Somatrogon | Makes the active ingredient and tests it |
Pfizer Laboratories Div Pfizer Inc |
0069-0505, 0069-0520 |
| Taliglucerase Alfa | Tests it |
Pfizer Laboratories Div Pfizer Inc |
0069-0106 |
| Trastuzumab | Makes the active ingredient and tests it |
Pfizer Laboratories Div Pfizer Inc |
0069-0305, 0069-0308 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| Dec 15, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 9, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 10, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Oct 15, 2013 | No problems found | Drug Quality Assurance | — |
| Apr 24, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Mar 10, 2017 inspection
- Deviations from laboratory control requirements 21 CFR 211.160(a)
Deviations from written test procedures and laboratory mechanisms are not justified.
Registered with FDA for: analysis; api manufacture; manufacture; pack.