Lonza Walkersville, Inc. – FDA 483, Nov 5, 2021

Lonza Walkersville, Inc., a medical device and biologics manufacturer, was cited with six observations during an FDA inspection from November 1-5, 2021. The inspection revealed significant deficiencies across its quality system, including inadequate procedures for CAPA, process validation, complaint handling, contamination control, and nonconforming product disposition. These issues indicate a systemic failure to maintain robust quality control and regulatory compliance.