Drug factory · FDA FEI 3003037054
Novo Nordisk A/S - G8, X9 M.Fl.
Novo Nordisk Park 99, Malov, Denmark
Problems found, fixed voluntarily at FDA's last inspection, Apr 17, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2011: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Estradiol | Makes it | Novo Nordisk | 0169-5176 |
| Estradiol and Norethindrone | Makes it | Amneal Pharmaceuticals | 69238-1251, 69238-1252 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 17, 2026 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Jun 16, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 12, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 1, 2018 | No problems found | Drug Quality Assurance | — |
| Apr 14, 2016 | No problems found | Drug Quality Assurance | — |
| Mar 14, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 8, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 8, 2011 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
Registered with FDA for: analysis; label; manufacture; pack.