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

Source: https://www.keypedia.com/records/483/genentech-inc/1cd09b7b-965e-44ed-b8cb-5c204ab45f19

> FDA 483 for Genentech, Inc. on February 01, 2023. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Genentech, Inc.
- Inspection Date: 2023-02-01
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Documents

- [CRL - Unknown Date](https://www.keypedia.com/records/crl/genentech-inc/82cfc039-6c70-459b-ad38-2e0ed36626fa)
- [EIR - 2022-10-07](https://www.keypedia.com/records/eir/genentech-inc/c790563c-45ba-439c-8c24-6cd1f80fcf3f)
- [483 - 2022-05-26](https://www.keypedia.com/records/483/genentech-inc/3b630c1e-0dc5-44a8-a456-256f25c6a163)
- [483 - 2011-09-27](https://www.keypedia.com/records/483/genentech-inc/18f90c1b-4f69-4c48-99f7-a22fc019324c)
- [483 - 2024-03-12](https://www.keypedia.com/records/483/genentech-inc/7887b305-0de6-472c-b596-8cbd94e8d300)

## Related Officers

- [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)
- [Regulatory Scientist at FDA](https://www.keypedia.com/people/yi-wang/f5355ae0-ae28-452f-829a-786b7ebc4791)

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