# FDA 483 - Novo Nordisk US Bio Production Inc. - February 14, 2020

Source: https://www.keypedia.com/records/483/novo-nordisk-us-bio-production-inc/f06cacda-b4ef-4e21-ab5f-5da19faa4684

> FDA 483 for Novo Nordisk US Bio Production Inc. on February 14, 2020. 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: 2020-02-14
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Novo Nordisk US Bio Production Inc. in West Lebanon, NH, a drug substance manufacturing facility, revealed significant deficiencies in quality control. Observations included inadequate laboratory controls for microbial detection, insufficient in-process hold time studies, and scientifically unsound corrective actions. Additionally, the firm failed to follow written procedures for contaminant identification and had inadequate written procedures for OOS investigations and employee training.

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## Related Officers

- [Arulvathani Arudchandran, Ph.D., Microbiologist](https://www.keypedia.com/people/arulvathani-arudchandran-phd-microbiologist/7e560c35-477b-44d7-9d09-ee990d8c0620)
- [Kathleen R. Jones, Ph.D., Microbiologist](https://www.keypedia.com/people/kathleen-r-jones-phd-microbiologist/99407232-210a-4a1b-a295-0d3e88fab80c)

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

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321