483
AnaptysBioAnaptysBio – FDA 483, Apr 29, 2026
Record Details
AnaptysBio, a sponsor of clinical studies in San Diego, CA, received a Form 483 for failing to adequately oversee and monitor its clinical trials. The inspection revealed significant deficiencies in monitoring plans, data query resolution, monitoring report sign-offs, and site qualification documentation. These issues indicate a lack of proper control over critical aspects of clinical study management.
View Company Profile
ID · 03bc24b8-54f7-4a3a-a5d7-ccfa2d0bdfd4
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.