Gilead Sciences, Inc. – FDA 483, Jan 5, 2000

An FDA inspection of Gilead Sciences, Inc. in Foster City, CA, focused on Adverse Drug Event (ADE) reporting, revealed significant deficiencies. The firm was cited for insufficient quality assurance, lack of written procedures for MedWatch Form 3500A data accuracy, follow-up reporting, and investigation of conflicting information. Additionally, issues were noted with system validation and the absence of a plan for data merging.