FDA EIR - Gilead Sciences, Inc. - July 25, 2014

A recent FDA inspection of Gilead Sciences, Inc. in Foster City, CA, conducted from July 15-25, 2014, served as both a pre-approval inspection for new drug applications (NDAs) and a routine Good Manufacturing Practices (cGMP) assessment. This inspection also followed up on significant deficiencies identified in a prior 2013 inspection, which resulted in 15 observations. The current inspection focused on the company's quality, materials, and laboratory control systems. Investigators identified two primary concerns, documented in an FDA Form 483. First, the company failed to adequately investigate the root causes of several discrepancies in receiving GMP samples and to implement effective corrective and preventive actions. Issues included missing samples, misdirected shipments, and samples not being properly logged into the electronic tracking system. Second, there was a lack of a consistent naming convention for samples within the laboratory software, coupled with insufficient audit trail reviews for instruments. The inspection was conducted under FDA's compliance programs for pre-approval and drug manufacturing inspections. Gilead Sciences management committed to providing a written response to the FDA's observations within 15 business days. While some corrective actions from the previous inspection were noted as implemented, their effectiveness requires further verification in future inspections. The observations highlight the need for robust control over sample handling and laboratory data management to ensure product quality and regulatory compliance.