# FDA 483 - Novo Nordisk US Bio Production Inc. - December 09, 2025

Source: https://www.keypedia.com/records/483/novo-nordisk-us-bio-production-inc/460c3315-1445-4bbe-9435-11bed5143998

> FDA 483 for Novo Nordisk US Bio Production Inc. on December 09, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novo Nordisk US Bio Production Inc.
- Inspection Date: 2025-12-09
- Product Type: drugs
- Office Name: New England District Office
- Summary: NovoNordisk US Bio Production, Inc. in West Lebanon, New Hampshire, was inspected for Active Pharmaceutical Ingredient (API) manufacture and received a Form 483 with five observations. The inspection revealed significant issues including inadequate process validation, failures in the quality unit's oversight of CGMP compliance, insufficient cleaning and sanitization practices, and deficiencies in laboratory test procedures and microbial contamination control. These findings indicate a moderate to severe level of non-compliance with manufacturing and quality standards for drug substances intended for sterile finished drug products.

## Related Documents

- [483 - 2020-02-14](https://www.keypedia.com/records/483/novo-nordisk-us-bio-production-inc/f06cacda-b4ef-4e21-ab5f-5da19faa4684)
- [483 - 2023-07-25](https://www.keypedia.com/records/483/novo-nordisk-us-bio-production-inc/6c8c53e9-ce07-4e99-9c32-4f93c2ea07e7)

## Related Officers

- [Vivin George](https://www.keypedia.com/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)
- [Raihan A. Chowdhury](https://www.keypedia.com/people/raihan-a-chowdhury/739813d5-2f9b-4048-91c7-911fd595f8d3)
- [National Expert, Pharmaceutical](https://www.keypedia.com/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)

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

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144