# FDA 483 - Gilead Sciences, Inc. - July 22, 2020

Source: https://www.globalkeysolutions.net/records/483/gilead-sciences-inc/9e0555b0-3c5e-4b85-9607-53ee62563b81

> FDA 483 for Gilead Sciences, Inc. on July 22, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gilead Sciences, Inc.
- Inspection Date: 2020-07-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Gilead Sciences, Inc. in Foster City, CA, revealed significant issues with electronic record integrity and access during clinical investigations. The firm failed to ensure proper locking of study databases after data submission and allowed unauthorized staff to enter source data. Additionally, Gilead Sciences, Inc. failed to provide requested clinical investigation records to the FDA investigator during the inspection.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sandra-saniga/a1a89397-a095-46de-9355-aa1cd88d729a)

Company: https://www.globalkeysolutions.net/companies/gilead-sciences-inc/05c4ed0b-5c05-4c0e-996e-9e344fef905c

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