KEDPLASMA LLCDecember 16, 2025

FDA 483 - KEDPLASMA LLC - December 16, 2025

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An FDA inspection of KEDPLASMA LLC in Indianapolis, IN, revealed two significant observations. The firm was cited for failing to include the total volume of plasma on Source Plasma container labels. Additionally, an observation was made regarding a phlebotomist's failure to maintain aseptic technique during arm preparation, leading to potential contamination.

Company: KEDPLASMA LLC
Inspection Date: December 16, 2025
Product Type: Biologics
Office: Detroit District Office
Person: Lesley Mae P. Lutao

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ID · cd2942ec-2a67-40a2-9e51-3de71cd5fb94