Drug factory · FDA FEI 3003342394
AstraZeneca AB
Gartunavagen, Sodertalje, Sweden
Problems found, fixed voluntarily at FDA's last inspection, Dec 12, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
9 drug inspections on record since 2010: 3 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Benralizumab | Makes it | AstraZeneca Pharmaceuticals LP | 0310-1730, 0310-1745, 0310-1830 |
| Metoprolol | Makes it | Aralez Pharmaceuticals US Inc., Melinta Therapeutics, LLC, New American Therapeutics | 70347-025, 70347-050, 70347-100 +9 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 12, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 1, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 6, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 7, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 27, 2017 | No problems found | Drug Quality Assurance | — |
| Mar 28, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 29, 2012 | No problems found | Drug Quality Assurance | — |
| Dec 10, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 25, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.