# FDA 483 - Sandoz GmbH - Unknown Date

Source: https://www.keypedia.com/records/483/sandoz-gmbh/23280e38-3df8-412d-9e30-33854f8fe577

> FDA 483 for Sandoz GmbH on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sandoz GmbH
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Sandoz GmbH in Schaftennau, a drug substance and drug product manufacturer, identified several significant deficiencies. Observations included inadequate support for microbial hold times, insufficient controls for testing machines, and deficiencies in standard operating procedures. The firm also lacked proper material control and release procedures for materials used in aseptic processing.

## Related Documents

- [483 - 2016-07-05](https://www.keypedia.com/records/483/sandoz-gmbh/143d1153-fe05-43f3-a92e-c9a5646deaa0)
- [483 - 2023-01-12](https://www.keypedia.com/records/483/sandoz-gmbh/16d4f5ca-64b0-4d7e-9783-321517445f81)

## Related Officers

- [investigator](https://www.keypedia.com/people/laura-fontan/b27b02a3-9ab1-49df-b2bc-ee936b69d76a)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)
- [investigator](https://www.keypedia.com/people/marjorie-a-shapiro/f58a39a5-65a0-4f73-98cf-436b5f29d89a)
- [Deborah H. Schmiel](https://www.keypedia.com/people/deborah-h-schmiel/facfc308-52af-4353-902a-0d45d5d88020)

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