# FDA 483 - Sandoz GmbH - July 05, 2016

Source: https://www.keypedia.com/records/483/sandoz-gmbh/143d1153-fe05-43f3-a92e-c9a5646deaa0

> FDA 483 for Sandoz GmbH on July 05, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sandoz GmbH
- Inspection Date: 2016-07-05
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Sandoz GmbH in Langkampfen, Austria, revealed significant deficiencies in their quality system, laboratory controls, and aseptic processing areas. The firm failed to thoroughly investigate bioburden testing discrepancies, lacked validated procedures for component testing, and did not validate hold times for environmental monitoring samples. These issues indicate a lack of adequate controls to ensure product quality and safety.

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

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321