Lonza AGDecember 15, 2017

FDA 483 - Lonza AG - December 15, 2017

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Record Details

An FDA inspection of Lonza AG in Visp, Switzerland, a drug substance manufacturer, revealed one observation. The firm's master production instructions were found to be deficient, specifically lacking defined time and temperature limits for critical processing steps of a starting material. This indicates a potential issue with process control and consistency in manufacturing.

Company: Lonza AG
Inspection Date: December 15, 2017
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Maria J. Lopez-Barragan
Frances Namuswe
Tiara N Brown-Crosen

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ID · 8a04ca07-4b1d-4652-b808-fa39c435dba7