FDA 483 - Wacker Biotech B.V. - November 21, 2025

An FDA inspection of Wacker Biotech B.V. in Amsterdam, Netherlands, a drug substances manufacturer, revealed significant deficiencies in quality control and manufacturing processes. Observations included issues with endotoxin testing sample containers, inaccurate electronic data reconciliation, inadequate laboratory procedures for biological indicators, and failure to follow environmental monitoring protocols. Additionally, equipment cleaning procedures were found to be insufficient, posing a risk of contamination in classified production areas.