# FDA 483 - Gilead Sciences, Inc. - October 18, 2011

Source: https://www.globalkeysolutions.net/records/483/gilead-sciences-inc/a5e41bd2-9af6-4c95-861c-759948bdb5c9

> FDA 483 for Gilead Sciences, Inc. on October 18, 2011. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gilead Sciences, Inc.
- Inspection Date: 2011-10-18
- 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, identified a significant issue regarding deviations from written sampling plans. The firm failed to record and justify these deviations, specifically concerning test method validation protocols for standard and sample solution expiration periods and planned changes in analyst and sample preparation evaluations. This indicates a lack of proper documentation and justification for critical testing procedures.

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## Related Officers

- [ Assistant Country Director (USFDA India Office Drug Program)](https://www.globalkeysolutions.net/people/daniel-j-roberts/1e1836ac-8bca-4236-a267-33ee0456440c)

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