# FDA 483 - Novo Nordisk Pharmaceutical Industries LP - July 06, 2023

Source: https://www.keypedia.com/records/483/novo-nordisk-pharmaceutical-industries-lp/281bc5eb-3b36-4b84-8126-0d6364b9f962

> FDA 483 for Novo Nordisk Pharmaceutical Industries LP on July 06, 2023. 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: 2023-07-06
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Novo Nordisk Pharmaceutical Industries LP in Clayton, NC, an API manufacturer, was cited for significant deficiencies in quality control. The inspection revealed a failure to thoroughly investigate the cause of objectionable organisms found in intermediate Semaglutide API batches and inadequate microbial controls, including a lack of established microbial limits for in-process materials. These issues indicate a serious breakdown in ensuring product quality and safety.

## Related Documents

- [EIR - 2022-05-13](https://www.keypedia.com/records/eir/novo-nordisk-pharmaceutical-industries-lp/37bcd4d9-2dd4-4e51-9349-32184213bfa8)
- [483 - 2022-05-09](https://www.keypedia.com/records/483/novo-nordisk-pharmaceutical-industries-lp/83be62a1-a352-4d5a-a220-8eb28ceb43b9)
- [EIR - 2023-07-13](https://www.keypedia.com/records/eir/novo-nordisk-pharmaceutical-industries-lp/272bae5d-2bf6-49db-a557-0b48425a5816)
- [483 - 2023-07-13](https://www.keypedia.com/records/483/novo-nordisk-pharmaceutical-industries-lp/07f68227-1226-420a-b605-fb4e3475849f)

## Related Officers

- [Seneca D. Toms](https://www.keypedia.com/people/seneca-d-toms/3eda62a2-4c12-438f-805a-5e3efb0f2f94)
- [Medical Officer at FDA](https://www.keypedia.com/people/brittny-c-cargo/a3479241-5390-4ddb-b892-df0bac1c89cf)

Company: https://www.keypedia.com/companies/novo-nordisk-pharmaceutical-industries-lp/ae9a8861-e1ab-4878-a69f-e2f23284d455

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7