483
Gilead Sciences, Inc.FDA 483 - Gilead Sciences, Inc. - July 22, 2020
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · 9e0555b0-3c5e-4b85-9607-53ee62563b81