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

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.