# FDA 483 - Novo Nordisk Pharmaceutical Industries LP - August 29, 2024

Source: https://www.keypedia.com/records/483/novo-nordisk-pharmaceutical-industries-lp/69885d7f-9345-48e0-97ea-a22d06fb73a0

> FDA 483 for Novo Nordisk Pharmaceutical Industries LP on August 29, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novo Nordisk Pharmaceutical Industries LP
- Inspection Date: 2024-08-29
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Novo Nordisk Pharmaceutical Industries LP in Durham, NC, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate environmental controls for API storage, a lack of a comprehensive stability testing program, and insufficient hold time studies. Additionally, the firm failed to follow written procedures for blending alarms, demonstrated inadequate quality control oversight, and had an insufficient shipping validation for its Semaglutide API.

## Related Officers

- [Sarah C Zimmermann](https://www.keypedia.com/people/sarah-c-zimmermann/0101c7e4-40b9-446c-8db6-d56c847c00c3)
- [James Norman](https://www.keypedia.com/people/james-norman/2e917a36-505a-44ed-b4e3-3dc0ef90a1f0)
- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)
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- [National Expert, Pharmaceutical](https://www.keypedia.com/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)

Company: https://www.keypedia.com/companies/novo-nordisk-pharmaceutical-industries-lp/6bd6ea0d-568a-4f97-ba33-f6bbab29a175

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6