Rivopharm S.A.January 18, 2019

FDA 483 - Rivopharm S.A. - January 18, 2019

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Record Details

During an inspection of Rivopharm S.A. in Manno, Switzerland, the FDA observed a significant issue related to quality control procedures. The firm failed to ensure that changes to written procedures, specifically regarding equipment recipes and process parameters, were adequately reviewed and approved by the quality control unit. This indicates a lack of robust change control and process validation oversight.

Company: Rivopharm S.A.
Inspection Date: January 18, 2019
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Joey V. Quitania (Public Affairs Specialist)

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ID · 392efa75-cb07-454d-9c3a-31372ef740d2