483
ImpactLifeFDA 483 - ImpactLife - May 09, 2025
Discuss this record with AI
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.
Record Details
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.
Open in Dashboard
ID · 605a04d5-24e3-40d5-b34e-ff0a72bbfc66