483
Gilead Sciences, Inc.FDA 483 - Gilead Sciences, Inc. - January 22, 2024
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
Gilead Sciences, Inc. in Foster City, CA, was inspected regarding its Postmarketing Adverse Drug Experience (PADE) reporting. The inspection revealed significant deficiencies in the timely processing and submission of serious and unexpected adverse event reports. Specifically, 95 cases, including 25 involving death, were submitted beyond the required 15-day regulatory timeline.
Open in Dashboard
ID · 450911dd-b16c-4d24-9f1f-d8db6731ac1f