FDA 483 - Gilead Sciences, Inc. - January 22, 2024

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.