FDA 483 - Lonza Biologics, Inc. - November 03, 2020

Lonza Biologics Inc., a drug substance manufacturer in Portsmouth, NH, was cited for significant deficiencies during an FDA inspection. Observations included inadequate qualification of a utility system for microbiological control, poorly installed equipment and maintained facilities, and widespread failures to follow or adequately define Standard Operating Procedures across various manufacturing and laboratory operations. These issues indicate a lack of robust quality control and adherence to established protocols.