FDA 483 - KEDPLASMA LLC - June 26, 2023

KEDPLASMA LLC in Sanford, FL, was inspected by the FDA from June 22-26, 2023. The inspection revealed a significant issue where the responsible physician failed to review and sign accumulated laboratory data, specifically serum protein electrophoresis (SPE) results, within the required 14 days. This lapse led to subsequent plasma donations being collected from donors whose previous failed SPE results were not properly approved by the responsible physician.