Sandoz GmbHDecember 17, 2021

FDA 483 - Sandoz GmbH - December 17, 2021

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Record Details

An FDA inspection of Sandoz GmbH in Kundl, Austria, a drug substance manufacturer, revealed several significant deficiencies. Observations included inadequate inspection of sterile bottles, deficient environmental monitoring, lack of raw material packaging sanitization, and poor facility maintenance in raw material sampling areas. These issues indicate a need for improved quality control and facility management practices.

Company: Sandoz GmbH
Inspection Date: December 17, 2021
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Xianghong Jing
Wayne E. Seifert (Senior Regulatory Specialist)

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ID · 9790dfcf-53b0-4f69-a336-2cf511c6f4cc