FDA 483 - Lonza AG - March 29, 2019

Lona Pharma and Biotech in Visp, Switzerland, a drug substance manufacturer, was cited with five observations during an FDA inspection from March 25-29, 2019. The observations primarily concern inadequate testing and storage of intermediates and drug substances, deficiencies in validation studies, and issues with raw material handling, pest control, and QC analytical procedures. These findings indicate significant concerns regarding quality control and manufacturing practices.