FDA 483 - Octapharma Plasma, Inc. - December 20, 2024

An FDA inspection of Octapharma Plasma, Inc. in Terre Haute, IN, a source plasma center, identified a critical failure in aseptic technique during blood collection. A phlebotomist was observed contaminating a donor's venipuncture site by palpating it with a gloved hand after sterilization. This lapse posed an imminent hazard and required immediate intervention.