FDA 483 - Blood Assurance Inc - February 15, 2019

Blood Assurance Inc, a blood bank donor center in Cleveland, TN, was inspected by the FDA from February 13-15, 2019. The inspection identified a failure to provide adequate privacy for individuals undergoing eligibility examinations as blood donors. This issue stemmed from a computer screen used for self-interviews being visible from the blood collection area due to the absence of a privacy screen protector.