FDA EIR - Gilead Sciences, Inc. - December 17, 2021

An FDA surveillance inspection of Gilead Sciences Inc.'s La Verne, CA facility was conducted from December 6 to December 17, 2021. This inspection, carried out under current Good Manufacturing Practices (cGMP) regulations and in response to a request from EU authorities, aimed to assess the sterile drug product manufacturer's operations, including those for AmBisome, Veklury (Remdesivir), and Truvada.

At the conclusion of the inspection, the FDA issued a four-item Form FDA-483, detailing observations related to compliance deficiencies. The main issues identified were: inadequate validation of aseptic processes for sterile drug products, unwritten or inadequately followed procedures within the quality control unit, insufficient training for employees involved in drug product manufacturing, and poor maintenance of facility buildings.

These observations highlight areas where the company's practices did not fully align with regulatory expectations for ensuring product quality and safety. Gilead Sciences Inc.'s management acknowledged the findings and committed to providing a written response to the agency within 15 business days, outlining their corrective and preventive actions to address the identified issues.