# FDA MEMO - Novo Nordisk A/S - March 25, 2024

Source: https://www.keypedia.com/records/memo/novo-nordisk-as/c64eef41-5e75-4ec1-8077-7d00df21947b

> FDA MEMO for Novo Nordisk A/S on March 25, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: MEMO
- Company Name: Novo Nordisk A/S
- Inspection Date: 2024-03-25
- Product Type: drugs
- Office Name: Office of Pharmaceutical Manufacturing Assessment
- Summary: Following an inspection conducted from March 15, 2024, to March 25, 2024, the U.S. Food and Drug Administration (FDA) issued a formal communication to Novo Nordisk A/S regarding its manufacturing facility located in Kalundborg, Denmark. This communication serves as the official dispatch of the Establishment Inspection Report (EIR) following the conclusion of the agency's assessment. Under the regulatory framework of 21 CFR 20.64(d)(3) and 21 CFR Part 20, the FDA releases these reports to the inspected establishment once an inspection is deemed "closed." While the provided documentation functions primarily as a transmittal letter rather than a list of specific deficiencies, the EIR contains the narrative findings of the FDA's site visit. The agency’s release of this document is part of a broader initiative to increase transparency within the regulated pharmaceutical industry and ensure compliance with federal standards. Although specific violations are not enumerated in this cover letter, the document signifies the completion of the investigative process for the specified timeframe. Novo Nordisk A/S is required to review the enclosed redacted report, which may have been edited in accordance with the Freedom of Information Act (FOIA). If the company has further inquiries or requires clarification regarding the report's contents, they are instructed to contact the Office of Pharmaceutical Manufacturing Assessment (OPMA) via the provided official communication channels. This administrative step is crucial for maintaining the quality and safety standards mandated by the FDA for global pharmaceutical manufacturing sites.

## Related Documents

- [483 - 2023-05-04](https://www.keypedia.com/records/483/novo-nordisk-as/c88acfb5-d361-4369-8bff-87d2b9102820)
- [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)

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

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-manufacturing-assessment/fe47b0bd-c1c6-4458-a8c9-15e4b073d3df