Genentech, Inc.January 31, 2023

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

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Record Details

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.

Company: Genentech, Inc.
Inspection Date: January 31, 2023
Product Type: Biologics
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Yi Wang (Regulatory Scientist at FDA)
Nayan J. Patel (Senior Lead Reviewer and Intercenter Consult Team Leader)
Michael R. Shanks (Investigator)

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