# FDA 483 - Novo Nordisk A/S - May 04, 2023

Source: https://www.keypedia.com/records/483/novo-nordisk-as/c88acfb5-d361-4369-8bff-87d2b9102820

> FDA 483 for Novo Nordisk A/S on May 04, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novo Nordisk A/S
- Inspection Date: 2023-05-04
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Novo Nordisk A/S in Kalundborg, Denmark, revealed significant deficiencies in contamination control, investigation of discrepancies, and complaint handling. The firm experienced multiple mold and bacterial recoveries in manufacturing areas, coupled with inadequate environmental monitoring and disinfection procedures. Additionally, investigations into product deviations and customer complaints were found to be insufficient, indicating a need for improved quality control and robust procedural adherence.

## Related Documents

- [EIR - 2024-03-25](https://www.keypedia.com/records/eir/novo-nordisk-as/e5940682-7d77-485a-a366-11b1f33ca5dc)
- [483 - 2024-03-25](https://www.keypedia.com/records/483/novo-nordisk-as/a1d0c5be-baef-49e2-8029-c33585c3f80a)
- [483 - 2024-03-25](https://www.keypedia.com/records/483/novo-nordisk-as/da5518cf-dd42-4d5b-b2f7-bdbb6dd3182c)
- [MEMO - 2024-03-25](https://www.keypedia.com/records/memo/novo-nordisk-as/c64eef41-5e75-4ec1-8077-7d00df21947b)

## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.keypedia.com/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)
- [Sergey S. Akimov](https://www.keypedia.com/people/sergey-s-akimov/4eca8d78-ef17-49a7-aaa1-5fa8fecf0383)
- [Mikhail Ovanesov](https://www.keypedia.com/people/mikhail-ovanesov/5167a693-fb5c-485d-b8e9-50ce8a6bdd90)
- [Unmesh Ranan](https://www.keypedia.com/people/unmesh-ranan/699c55c1-d1a9-4b77-a175-244a894dc0ef)

Company: https://www.keypedia.com/companies/novo-nordisk-as/b48359f1-0bb7-4fff-80dd-688aab40951b

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd