FDA 483 - Gilead Sciences, Inc. - February 18, 2026

From February 9 to February 18, 2026, the FDA inspected the Gilead Sciences, Inc. manufacturing facility in La Verne, California. The inspection identified several significant operational deficiencies across the quality, laboratory, and production systems, conducted under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. Primary violations included the quality unit"s failure to adhere to stability study protocols, leading to samples being stored in unqualified environments without adequate temperature tracking. The report also highlighted laboratory control issues, such as unreliable analytical testing methods and insufficient access controls for testing samples. Furthermore, the facility utilized non-standard protective wrapping for reserve samples that could potentially hide product degradation during annual inspections. Other critical findings involved improper techniques during sterility testing and deficient airflow visualization studies that failed to prove the effectiveness of contamination controls in sterile manufacturing areas. Physical inspections also revealed leaks in utility systems that current procedures failed to address. While these observations do not constitute a final agency judgment, Gilead Sciences is required to address these issues through corrective actions or formal objections to ensure compliance with manufacturing safety and quality standards.