Mirum Pharmaceuticals, Inc. – FDA 483, Jul 24, 2026

Mirum Pharmaceuticals, Inc. in Foster City, CA, was cited for failing to report serious and unexpected adverse drug experiences to the FDA within 15 calendar days. The inspection revealed inadequate oversight of their pharmacovigilance vendor, resulting in approximately 15% of expedited reports being submitted late over a two-year period. Furthermore, the firm lacked finalized deviations or CAPAs for several of these delayed submissions.