Drug factory · FDA FEI 3002617771
AstraZeneca Pharmaceuticals LP
633 Research Court, Frederick, MD, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 19, 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: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nirsevimab | Makes the active ingredient and tests it | Sanofi Vaccines US Inc. | 49281-574, 49281-575 |
| Tralokinumab | Makes the active ingredient | LEO Pharma Inc. | 50222-346, 50222-350 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 19, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 17, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 24, 2015 | No problems found | Drug Quality Assurance | — |
| Sep 21, 2012 | No problems found | Drug Quality Assurance | — |
| Jun 18, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture; pack.