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483
•Sandoz GmbH

FDA 483 - Sandoz GmbH

Record Details

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.

Company
Sandoz GmbH
Product type
drugs
Office
International Compliance Team
People
  • Marjorie A. Shapiro (investigator)
  • Deborah H. Schmiel
  • Laura Fontan (investigator)
  • Michael R. Shanks (Investigator)
View Company Profile

ID · 23280e38-3df8-412d-9e30-33854f8fe577

Other documents for Sandoz GmbH
  • 483 - 2023-01-12January 12, 2023
  • 483 - 2018-02-20February 20, 2018
  • 483 - 2016-07-05July 5, 2016

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