Drug factory · FDA FEI 3002807751
Novo Nordisk A/S
Hallas Alle 1, Kalundborg, Denmark
Problems found, fixed voluntarily at FDA's last inspection, Jun 10, 2025.
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 2012: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Coagulation Factor Viia Recombinant Human | Makes the active ingredient | Novo Nordisk | 0169-7010, 0169-7020, 0169-7040 +5 |
| Insulin Degludec | Makes the active ingredient | Novo Nordisk Pharma, Inc. | 73070-400, 73070-403, 73070-503 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 10, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 2, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 6, 2019 | No problems found | Drug Quality Assurance | — |
| Aug 29, 2017 | No problems found | Drug Quality Assurance | — |
| Mar 7, 2014 | No problems found | Drug Quality Assurance | — |
| Mar 9, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.