FDA 483 - Gilead Sciences, Inc.

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.