# FDA 483 - Genentech, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/genentech-inc/eae90920-9665-4fba-aa4f-c73542a1798d

> FDA 483 for Genentech, Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genentech, Inc.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: During an inspection from May 17-21, 2021, the FDA observed that Genentech, Inc. in Hillsboro, OR, lacked adequate control procedures for monitoring manufacturing processes. Specifically, the firm failed to establish controls to address variability in the fill volume of drug product vials, including during vial filling and at batch completion. This indicates a significant concern regarding the quality control of their pharmaceutical manufacturing operations.

## Related Officers

- [Barbara Breithaupt](https://www.keypedia.com/people/barbara-breithaupt/710dedb7-6108-4ece-8ce3-e31a0c734cfd)

Company: https://www.keypedia.com/companies/genentech-inc/97918967-ab2f-4019-9954-a0d687852d27

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