FDA 483 - ImpactLife - May 09, 2025

ImpactLife in Monona, WI, was inspected from May 8-9, 2025, and received one observation. The inspection found that written standard operating procedures for the storage and distribution of blood and blood components were not always followed. Specifically, visual inspections of relocated Red Blood Cell units were not performed as required by SOP 8222, despite being documented as acceptable.