Gilead Sciences, Inc. – FDA 483, Dec 17, 2021

Gilead Sciences Inc. in La Verne, CA, a sterile drug manufacturer, was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies in aseptic process validation, quality control procedures, employee training, and facility maintenance. These issues primarily concern the manufacturing and storage of sterile injectable drug products, indicating a moderate level of non-compliance.