# FDA 483 - Genentech Inc - August 13, 2018

Source: https://www.keypedia.com/records/483/genentech-inc/3f7f981c-2ce5-45b1-aac0-d338eafdd8c4

> FDA 483 for Genentech Inc on August 13, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genentech Inc
- Inspection Date: 2018-08-13
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Genentech Inc. in Vacaville, CA, a drug substance manufacturer, received a Form 483 citing three significant observations. The inspection revealed deficiencies in label reconciliation procedures, inadequate documentation of cleaning and sanitizing materials for equipment, and insufficient computer controls to prevent manipulation or omission of electronic raw data, particularly for raw material testing.

## Related Officers

- [National Program Expert- Pharmacy Compounding](https://www.keypedia.com/people/lucila-b-nwatu/3d1c9670-8206-425c-bddd-32e395293042)
- [investigator](https://www.keypedia.com/people/amir-alavi/d7179128-eb3f-489e-97cf-e2c5e5539a00)

Company: https://www.keypedia.com/companies/genentech-inc/42ff204c-813d-4c97-85ad-70ce13a1d643

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b