483
Lonza AGLonza AG – FDA 483, Apr 4, 2025
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.
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ID · 258011de-5647-45fe-8dbf-b3aeb72657c2
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