# FDA EIR - Novo Nordisk Pharmaceutical Industries LP - May 13, 2022

Source: https://www.keypedia.com/records/eir/novo-nordisk-pharmaceutical-industries-lp/37bcd4d9-2dd4-4e51-9349-32184213bfa8

> FDA EIR for Novo Nordisk Pharmaceutical Industries LP on May 13, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Novo Nordisk Pharmaceutical Industries LP
- Inspection Date: 2022-05-13
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An FDA pre-approval inspection of Novo Nordisk Pharmaceutical Industries LP's Clayton, NC facility, conducted from May 9-13, 2022, focused on evaluating the site's adherence to current Good Manufacturing Practices (cGMP) for the non-sterile active pharmaceutical ingredient (API) Semaglutide, destined for NDA #213051 Oral Semaglutide / Rybelsus® tablets. This was the facility's inaugural FDA inspection. The inspection resulted in three significant observations documented on an FDA Form 483.

Key issues identified included the company's failure to recognize *Burkholderia cepacia* as an objectionable organism within its water system, deficiencies in equipment cleaning procedures to prevent cross-contamination, and the absence of established written procedures to prevent contamination of equipment, raw materials, and active pharmaceutical ingredients. These findings indicated non-compliance with the Food Drug and Cosmetic Act's adulteration provisions and cGMP requirements, as guided by CPGM 7346.832 Pre-Approval Inspections and ICH Q7 Guidance.

Novo Nordisk management, represented by Corporate Vice President API Mr. Leonardo Costa Siqueira, acknowledged the observations and committed to submitting a written response within fifteen business days. The FDA cautioned that these conditions could lead to legal sanctions, including the potential withholding of the New Drug Application approval.

## Related Documents

- [483 - 2022-05-09](https://www.keypedia.com/records/483/novo-nordisk-pharmaceutical-industries-lp/83be62a1-a352-4d5a-a220-8eb28ceb43b9)
- [483 - 2023-07-06](https://www.keypedia.com/records/483/novo-nordisk-pharmaceutical-industries-lp/281bc5eb-3b36-4b84-8126-0d6364b9f962)
- [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

- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)
- [company_representative](https://www.keypedia.com/people/paul-snyder/34e0a337-ab93-42fd-bead-e07e033407ad)
- [company_representative](https://www.keypedia.com/people/christine-moller-jensen/41ea6b08-9b22-440a-9049-e83668cc8ee8)
- [company_representative](https://www.keypedia.com/people/henrik-friese/82a56d97-76a1-4441-8288-00b742c1b205)
- [company_representative](https://www.keypedia.com/people/helen-scholer/8da9c882-ca46-4242-888e-af4f73a0baad)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c