# FDA 483 - Sandoz GmbH - December 17, 2021

Source: https://www.globalkeysolutions.net/records/483/sandoz-gmbh/9790dfcf-53b0-4f69-a336-2cf511c6f4cc

> FDA 483 for Sandoz GmbH on December 17, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sandoz GmbH
- Inspection Date: 2021-12-17
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Sandoz GmbH in Kundl, Austria, a drug substance manufacturer, revealed several significant deficiencies. Observations included inadequate inspection of sterile bottles, deficient environmental monitoring, lack of raw material packaging sanitization, and poor facility maintenance in raw material sampling areas. These issues indicate a need for improved quality control and facility management practices.

## Related Documents

- [483 - 2018-09-10](https://www.globalkeysolutions.net/records/483/sandoz-gmbh/b84529ea-b61e-4feb-9eaf-6b2903e68cbb)

## Related Officers

- [Xianghong Jing](https://www.globalkeysolutions.net/people/xianghong-jing/4a6bdc97-4ce6-40a9-bd03-0ed8c49e742f)
- [Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.globalkeysolutions.net/companies/sandoz-gmbh/06a6ffcd-311c-4e6b-8087-573378a1ad87

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