483
Lonza AGLonza AG – FDA 483, Dec 15, 2017
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.
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ID · 8a04ca07-4b1d-4652-b808-fa39c435dba7
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