FDA 483 - KEDPlasma, LLC - November 10, 2022

An FDA inspection of KEDPLASMA, LLC in Pensacola, FL, a Source Plasma Establishment, revealed significant deficiencies in its quality system. The firm failed to adequately investigate major deviations and ensure the effectiveness of corrective and preventative actions. Additionally, employees did not consistently follow standard operating procedures for plasma collection, specifically concerning venipuncture site preparation and aseptic technique.