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

An FDA Pre-License Inspection of Lonza Houston, Inc., a viral vector manufacturer, was conducted from December 3-10, 2020. This was the first inspection of the Houston facility, performed under Compliance Program Guide 7345.848 for Biological Products, in support of a Biologics License Application (BLA). The inspection covered various quality systems, including production, laboratory, materials, and facilities.The inspection revealed several significant issues, leading to the issuance of a four-item Form FDA 483, Inspectional Observations. Key findings included inadequate physical and electronic control of material storage areas, such as a lack of separate storage for different product statuses and poorly designed labels contributing to mix-up risks. A freezer unit for product storage was noted as poorly maintained and disorganized, and quarantine material freezers were found unlocked. Furthermore, the identity of incoming raw material batches was not consistently verified, and written procedures were not always followed during manufacturing operations. Inadequate microbial contamination controls were also observed.Beyond the formal observations, discussions with management highlighted additional concerns, such as the need for more thorough audit trail reviews for electronic data, issues with processing utensils, temperature alarms being turned off for incubators, and untimely quality assurance review of cleaning logbooks. Lonza Houston, Inc. is required to formally respond to the Form FDA 483 by detailing their corrective and preventive actions to address these identified deficiencies.