# FDA 483 - Gilead Sciences, Inc. - January 22, 2024

Source: https://www.keypedia.com/records/483/gilead-sciences-inc/450911dd-b16c-4d24-9f1f-d8db6731ac1f

> FDA 483 for Gilead Sciences, Inc. on January 22, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gilead Sciences, Inc.
- Inspection Date: 2024-01-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Gilead Sciences, Inc. in Foster City, CA, was inspected regarding its Postmarketing Adverse Drug Experience (PADE) reporting. The inspection revealed significant deficiencies in the timely processing and submission of serious and unexpected adverse event reports. Specifically, 95 cases, including 25 involving death, were submitted beyond the required 15-day regulatory timeline.

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## Related Officers

- [Scott N. Lim](https://www.keypedia.com/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)
- [Cynthia J. Tsui](https://www.keypedia.com/people/cynthia-j-tsui/e02b5fd2-e90b-47a7-bbc2-e658f160c4ae)

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

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