Lonza AGApril 4, 2025

FDA 483 - Lonza AG - April 04, 2025

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Record Details

An FDA inspection of Lonza AG in Visp, Switzerland, revealed deficiencies in procedures designed to prevent microbiological contamination of sterile drug products. Operators were observed covering sterile openings and blocking first air during aseptic assembly and stopper addition operations. These findings indicate a failure to establish and follow adequate controls for sterile manufacturing.

Company: Lonza AG
Inspection Date: April 4, 2025
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Operations
People: Melissa D. Ray
Thuy T. Nguyen ( Investigator, Consumer Safety Officer)
Hyung-yul Lee

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ID · 258011de-5647-45fe-8dbf-b3aeb72657c2