# FDA 483 - Novartis Pharma Stein AG - December 04, 2018

Source: https://www.keypedia.com/records/483/novartis-pharma-stein-ag/3e713a20-3bd1-4991-aad5-bac1eccc2725

> FDA 483 for Novartis Pharma Stein AG on December 04, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Pharma Stein AG
- Inspection Date: 2018-12-04
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Novartis Pharma Stein AG, a biological drug manufacturer in Stein, Switzerland, revealed significant deficiencies. Observations included inadequate environmental monitoring during aseptic processing, poor facility maintenance with a leaking cooling unit affecting drug product storage, and pre-dating of production and process control documentation. These issues indicate a lack of control over critical manufacturing processes and facility conditions.

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## Related Officers

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd