# FDA 483 - Novo Nordisk US Bio Production Inc. - July 25, 2023

Source: https://www.globalkeysolutions.net/records/483/novo-nordisk-us-bio-production-inc/6c8c53e9-ce07-4e99-9c32-4f93c2ea07e7

> FDA 483 for Novo Nordisk US Bio Production Inc. on July 25, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novo Nordisk US Bio Production Inc.
- Inspection Date: 2023-07-25
- Product Type: biologics
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Novo Nordisk US Bio Production Inc. in West Lebanon, NH, a biologic bulk drug substance manufacturer, was cited for significant deficiencies across three observations. The inspection revealed failures in equipment cleaning and sanitization leading to persistent microbial contamination and biofilm issues, inadequate controls over computerized systems resulting in data integrity concerns, and systemic problems with employee training for CGMP functions. These findings indicate a lack of control over critical manufacturing processes and quality systems.

## Related Documents

- [483 - 2020-02-14](https://www.globalkeysolutions.net/records/483/novo-nordisk-us-bio-production-inc/f06cacda-b4ef-4e21-ab5f-5da19faa4684)
- [483 - 2025-12-09](https://www.globalkeysolutions.net/records/483/novo-nordisk-us-bio-production-inc/460c3315-1445-4bbe-9435-11bed5143998)

## Related Officers

- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.globalkeysolutions.net/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)

Company: https://www.globalkeysolutions.net/companies/novo-nordisk-us-bio-production-inc/08f5214b-4db0-4d94-86ee-4ba9c3c28ea2

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7