# FDA 483 - Sandoz GmbH - September 10, 2018

Source: https://www.globalkeysolutions.net/records/483/sandoz-gmbh/b84529ea-b61e-4feb-9eaf-6b2903e68cbb

> FDA 483 for Sandoz GmbH on September 10, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sandoz GmbH
- Inspection Date: 2018-09-10
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Sandoz GmbH, an API and drug manufacturer in Kundl, Austria, was cited for significant deficiencies in its quality control systems. Observations included inadequate investigations into sterility failures, insufficient laboratory controls for critical surface monitoring, and a lack of validated sterilization processes. Additionally, the firm lacked written procedures for equipment cleaning and maintenance.

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## Related Officers

- [Microbiologist](https://www.globalkeysolutions.net/people/susan-t-hadman/512c3274-4da8-4f5a-a081-965ab5ec84e6)
- [Margaret M. Annes](https://www.globalkeysolutions.net/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

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