FDA 483 - Lonza Houston, Inc - November 18, 2025

Lonza Houston, Inc. in Houston, TX, received a Form 483 for significant deficiencies in its aseptic processing areas, primarily concerning microbial contamination control. The inspection revealed numerous environmental monitoring excursions, adverse trends of mold and bacterial recoveries, and subsequent impact on drug substance batches. Additionally, the firm failed to adequately extend investigations of discrepancies to all potentially affected drug product batches.