Drug factory · FDA FEI 3000151819
Novo Nordisk A/S
Novo Alle 1, Bagsvaerd, Denmark
Problems found, fixed voluntarily at FDA's last inspection, Oct 3, 2024.
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 2009: 4 with no problems, 4 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Insulin Degludec | Makes it | Novo Nordisk Pharma, Inc. | 73070-400, 73070-403, 73070-503 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 3, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 29, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 5, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 18, 2018 | No problems found | Drug Quality Assurance | — |
| Apr 8, 2016 | No problems found | Drug Quality Assurance | — |
| Sep 3, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Mar 20, 2012 | Serious problems, FDA action | Drug Quality Assurance | — |
| May 13, 2009 | No problems found | Bioresearch Monitoring | — |
| Mar 6, 2009 | No problems found | Drug Quality Assurance | — |
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 3, 2013 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials conform to appropriate standards of identity, strength, quality and purity. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are not written or followed.
Registered with FDA for: analysis; api manufacture; manufacture.