FDA 483 - Lonza Houston, Inc - December 10, 2020

An FDA inspection of Lonza Houston, Inc. in Houston, TX, revealed significant deficiencies across multiple areas of their viral vector manufacturing operations. The firm was cited for inadequate physical and electronic control of material storage, failure to verify the identity of incoming raw materials, non-adherence to written procedures, and insufficient microbial contamination controls. These observations indicate a need for improved adherence to Good Manufacturing Practices to prevent product mix-ups, ensure material quality, and maintain aseptic conditions.