FDA 483 - Biomat Holdings Mount Vernon Newark - July 15, 2025

An FDA inspection of Biomat Holdings Mount Vernon Newark in Newark, OH, identified a significant concern regarding phlebotomy site preparation. Inspectors observed phlebotomists palpating venipuncture sites after needle insertion, which compromises the sterile field. This practice raises concerns about the sterility of collected source plasma units and adherence to proper aseptic technique.