# FDA 483 - Novo Nordisk Pharmaceutical Industries LP - May 09, 2022

Source: https://www.globalkeysolutions.net/records/483/novo-nordisk-pharmaceutical-industries-lp/83be62a1-a352-4d5a-a220-8eb28ceb43b9

> FDA 483 for Novo Nordisk Pharmaceutical Industries LP on May 09, 2022. 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: 2022-05-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Novo Nordisk Pharmaceutical Industries, LP in Clayton, NC, a non-sterile API manufacturer, was cited for three observations during an FDA inspection. The findings included a failure to identify Burkholderia cepacia as an objectionable organism, inadequate cleaning validation and routine cleaning for production equipment, and a lack of written procedures for instrument component traceability and maintenance tags. These issues indicate deficiencies in contamination control and quality system procedures.

## Related Documents

- [EIR - 2022-05-13](https://www.globalkeysolutions.net/records/eir/novo-nordisk-pharmaceutical-industries-lp/37bcd4d9-2dd4-4e51-9349-32184213bfa8)
- [EIR - 2023-07-13](https://www.globalkeysolutions.net/records/eir/novo-nordisk-pharmaceutical-industries-lp/272bae5d-2bf6-49db-a557-0b48425a5816)
- [483 - 2023-07-13](https://www.globalkeysolutions.net/records/483/novo-nordisk-pharmaceutical-industries-lp/07f68227-1226-420a-b605-fb4e3475849f)
- [483 - 2023-07-06](https://www.globalkeysolutions.net/records/483/novo-nordisk-pharmaceutical-industries-lp/281bc5eb-3b36-4b84-8126-0d6364b9f962)

## Related Officers

- [Santos E. Camara](https://www.globalkeysolutions.net/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1