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 after sterilization by touching it with a gloved hand. This lapse in procedure posed an imminent hazard, requiring immediate intervention.