# FDA 483 - Novartis d.o.o. - July 21, 2023

Source: https://www.keypedia.com/records/483/novartis-doo/69691f9f-8517-4912-812d-f0f1d44c99fa

> FDA 483 for Novartis d.o.o. on July 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis d.o.o.
- Inspection Date: 2023-07-21
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Novartis Pharmaceutical Manufacturing LLC in Mengeš, Slovenia, a drug substance manufacturer, revealed significant deficiencies in quality unit oversight, manufacturing process controls, and environmental monitoring. Issues included errors in validation studies, conflicting sample storage information, inadequate batch record verification, and unsuitable environmental monitoring limits. The findings indicate a lack of robust quality systems and process control, potentially impacting product quality and safety.

## Related Officers

- [Bo Chi, Ph.D.](https://www.keypedia.com/people/bo-chi-phd/0016303e-704f-4a0a-ad1d-6ae4efdc1b19)
- [Michael Moses, Ph.D.](https://www.keypedia.com/people/michael-moses-phd/705eb939-be62-4d9b-bd7b-dbeb53607fc3)
- [Liqun Zhao, Ph.D.](https://www.keypedia.com/people/liqun-zhao-phd/dd72eb3b-6fa7-449a-8b8d-9d5e17c5c080)

Company: https://www.keypedia.com/companies/novartis-doo/55471e35-a203-4edf-a4b9-fe1ad0bb16fd

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4