Gilead Sciences, Inc.July 22, 2020

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

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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.

Company: Gilead Sciences, Inc.
Inspection Date: July 22, 2020
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West V
Person: Sandra Saniga (investigator)

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ID · 9e0555b0-3c5e-4b85-9607-53ee62563b81