# FDA 483 - Gilead Sciences, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/gilead-sciences-inc/b48d7486-8192-41f4-8c73-b357f29d663d

> FDA 483 for Gilead Sciences, Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gilead Sciences, Inc.
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Gilead Sciences, Inc. in Foster City, CA was inspected by the FDA from December 5-9, 2011. The inspection revealed significant issues related to laboratory controls and documentation practices. Specifically, the firm failed to conduct a re-injection reproducibility experiment during method validation and did not maintain original chromatograms, alongside a broader failure to document various critical aspects of study conduct, impacting data integrity.

## Related Documents

- [EIR - 2019-04-04](https://www.keypedia.com/records/eir/gilead-sciences-inc/122c5b07-52e0-4fe8-805d-f16159b2398e)
- [EIR - 2014-07-25](https://www.keypedia.com/records/eir/gilead-sciences-inc/4d8c1bd4-44f6-42a9-9c13-5b7a7fe8c709)
- [EIR - 2014-01-15](https://www.keypedia.com/records/eir/gilead-sciences-inc/c7b9997b-f0fa-4033-9588-5b86b5883afb)
- [483 - 2024-01-22](https://www.keypedia.com/records/483/gilead-sciences-inc/450911dd-b16c-4d24-9f1f-d8db6731ac1f)
- [CRL - Unknown Date](https://www.keypedia.com/records/crl/gilead-sciences-inc/72a781e8-af07-40d3-9619-cd73a63e56d8)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/arindam-dasgupta/4337d565-c1cb-4a78-aeae-f5afc35644d8)
- [Kevin P. Foley](https://www.keypedia.com/people/kevin-p-foley/66aed833-31fa-4ae9-bcfd-b266b957642c)

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