FDA 483 - Suncoast Community Blood Bank Inc - April 13, 2022

An FDA inspection of Suncoast Community Blood Bank Inc in Sarasota, FL, revealed deficiencies in phlebotomy site preparation procedures. Observations included an employee failing to complete a targeted swab step and experiencing significant delays between preparation steps, as well as an employee contaminating sterile gauze with non-sterile gloves. These issues indicate a failure to ensure maximum assurance of a sterile container of Whole Blood.