# FDA 483 - Sandoz GmbH - January 12, 2023

Source: https://www.keypedia.com/records/483/sandoz-gmbh/16d4f5ca-64b0-4d7e-9783-321517445f81

> FDA 483 for Sandoz GmbH on January 12, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sandoz GmbH
- Inspection Date: 2023-01-12
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Sandoz GmbH in Langkampfen, Austria, a pharmaceutical manufacturer, revealed two significant deficiencies. The firm failed to adequately establish procedures for verifying the effectiveness of corrective and preventive actions (CAPA) and for properly investigating product complaints, specifically concerning malfunctions of Hyrimoz. These issues indicate a moderate level of non-compliance with quality system requirements.

## Related Documents

- [483 - 2016-07-05](https://www.keypedia.com/records/483/sandoz-gmbh/143d1153-fe05-43f3-a92e-c9a5646deaa0)
- [483 - Unknown Date](https://www.keypedia.com/records/483/sandoz-gmbh/23280e38-3df8-412d-9e30-33854f8fe577)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.keypedia.com/companies/sandoz-gmbh/02a3eaeb-a765-43ae-873b-93d1d1523696

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