# Genentech, Inc. – FDA 483, Jan 31, 2023

Source: https://www.keypedia.com/records/483/genentech-inc/e020acbc-f66e-4314-a8bc-c156ef8c9a94

> FDA 483 for Genentech, Inc. on January 31, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genentech, Inc.
- Inspection Date: 2023-01-31
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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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## Related Officers

- [Regulatory Scientist at FDA](https://www.keypedia.com/people/yi-wang/f5355ae0-ae28-452f-829a-786b7ebc4791)
- [Senior Lead Reviewer and Intercenter Consult Team Leader](https://www.keypedia.com/people/nayan-j-patel/0436f014-4b1b-4e54-8df0-576d51a354b2)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

Company: https://www.keypedia.com/companies/genentech-inc/709aa262-e8df-42fa-bec6-02673e7f52ec

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd