# FDA 483 - Novartis Pharma Stein AG - May 19, 2026

Source: https://www.keypedia.com/records/483/novartis-pharma-stein-ag/7256aae6-5bf4-4371-ab4d-8a6f90ee21a6

> FDA 483 for Novartis Pharma Stein AG on May 19, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Pharma Stein AG
- Inspection Date: 2026-05-19
- Product Type: biologics
- Office Name: Division of Blood Components and Devices
- Summary: Novartis Pharma Stein AG, a licensed biological drug manufacturer in Stein Ag, Switzerland, was cited for significant deficiencies in its aseptic processing and quality control systems. The inspection revealed a failure to perform critical active air sampling during sterile drug product filling and a systemic breakdown in the environmental monitoring program. These issues led to the release of product without complete quality unit oversight, indicating a serious lack of control over manufacturing processes and quality assurance for sterile products.

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## Related Officers

- [Travis S. Bradley](https://www.keypedia.com/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)

Company: https://www.keypedia.com/companies/novartis-pharma-stein-ag/06be1f01-8421-471e-9d38-475fef9a9c5b

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917