FDA 483 - Genentech, Inc. - January 31, 2023

Genentech, Inc. in South San Francisco, CA, received a Form 483 citing significant deficiencies in aseptic processing and quality control for its Glofitamab drug product. The inspection revealed issues with microbial cross-contamination control, inadequate personnel and environmental monitoring, and insufficient validation oversight for material storage. Additionally, basic facility maintenance was found lacking with the absence of hot water in washing facilities.