483
AnaptysBioFDA 483 - AnaptysBio - April 29, 2026
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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.
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ID · 03bc24b8-54f7-4a3a-a5d7-ccfa2d0bdfd4