483
Genentech, Inc.Genentech, Inc. – FDA 483, Jan 31, 2023
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.
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ID · e020acbc-f66e-4314-a8bc-c156ef8c9a94
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