FDA 483 - Gilead Sciences, Inc. - July 22, 2020

An FDA inspection of Gilead Sciences, Inc. in Foster City, CA, revealed significant issues with electronic record integrity and access during clinical investigations. The firm failed to ensure proper locking of study databases after data submission and allowed unauthorized staff to enter source data. Additionally, Gilead Sciences, Inc. failed to provide requested clinical investigation records to the FDA investigator during the inspection.