FDA 483 - Genentech, Inc. - February 01, 2023

Genentech, Inc. in South San Francisco, CA, was inspected regarding its manufacturing operations for Glofitamab drug product. The inspection revealed significant deficiencies in microbial cross-contamination control, aseptic processing personnel and environmental monitoring, and quality oversight of validation activities. Additionally, basic facility issues like a lack of hot water in washing facilities were noted, indicating a moderate level of concern across multiple operational areas.