FDA 483 - Biomat USA, Inc - February 11, 2020

An FDA inspection of Biotest USA, Inc.'s plasmapheresis center in Cincinnati, OH, identified two significant observations. The firm was cited for phlebotomists not adhering to standard operating procedures for arm scrubs, which could compromise the sterility of blood containers. Additionally, the facility failed to provide adequate private space for donor eligibility examinations, leading to donors standing in a crowded waiting area.