Drug factory · FDA FEI 3003150913
Pfizer Health AB
Mariefredsvagen 37, Strangnas, Sweden
Problems found, fixed voluntarily at FDA's last inspection, Mar 6, 2026.
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
| Drug | Role | For | NDC |
|---|---|---|---|
| Dalteparin | Makes the active ingredient and tests it | Pfizer Laboratories Div Pfizer Inc | 0069-0195, 0069-0196, 0069-0206 +6 |
| Meningococcal Groups A, B, C, W, and Y Vaccine | 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 the active ingredient and tests it | Wyeth Pharmaceutical Division of Wyeth Holdings LLC | 0005-0100 |
| Somatropin | Makes the active ingredient and tests it | Pfizer Laboratories Div Pfizer Inc | 0013-2626, 0013-2646, 0013-2649 +9 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 6, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 13, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 13, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 17, 2017 | No problems found | Drug Quality Assurance | — |
| Sep 6, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 27, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.