# FDA 483 - Gilead Sciences, Inc. - November 03, 2099

Source: https://www.keypedia.com/records/483/gilead-sciences-inc/eb61972e-bd1c-4e2e-8add-43bb7af03c36

> FDA 483 for Gilead Sciences, Inc. on November 03, 2099. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gilead Sciences, Inc.
- Inspection Date: 2099-11-03
- 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, focused on Adverse Drug Event (ADE) reporting, revealed significant deficiencies. The firm was cited for insufficient quality assurance, lack of written procedures for MedWatch Form 3500A data accuracy, follow-up reporting, and investigation of conflicting information. Additionally, issues were noted with system validation and the absence of a plan for data merging.

## Related Officers

- [Jeffrey M. Watson](https://www.keypedia.com/people/jeffrey-m-watson/b85b4298-338c-4523-bbd1-58fc3c297b3b)
- [Marie K. Kinkade](https://www.keypedia.com/people/marie-k-kinkade/ceb8ade3-5336-43e8-89e1-559cd905df54)

Company: https://www.keypedia.com/companies/gilead-sciences-inc/a57ab5a9-2c49-492f-9218-51c9b78dd290

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