# FDA 483 - Gilead Sciences, Inc. - July 17, 2018

Source: https://www.globalkeysolutions.net/records/483/gilead-sciences-inc/6e644d94-ebcd-4830-b63d-611baa563e49

> FDA 483 for Gilead Sciences, Inc. on July 17, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gilead Sciences, Inc.
- Inspection Date: 2018-07-17
- 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 drug safety and public health practices. The inspection revealed a significant failure to report serious and unexpected adverse drug experiences to the FDA within the required 15 calendar days. This indicates a lapse in pharmacovigilance and regulatory compliance.

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## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/diane-c-van-leeuwen/98af0d70-2db1-4132-8193-fcccf8841960)
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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