FDA 483 - Hemarus, LLC - March 12, 2020

Hemarus, LLC, a plasma donor center in Jacksonville, FL, was inspected by the FDA from March 9-12, 2020. The inspection revealed issues with equipment standardization, specifically a hematocrit testing machine, and a lack of proper donor notification for transfusion-transmitted infection test results. Additionally, a phlebotomist was observed compromising the sterility of a venipuncture site.