FDA 483 - Versiti Illinois Inc - August 12, 2019

An FDA inspection of Versiti Illinois Inc, a blood bank in Tinley Park, IL, identified a significant lapse in quality control. The firm failed to conduct thorough investigations into unexplained discrepancies, specifically regarding 27 units of blood products that were reported lost over a two-year period. This indicates a serious concern with the firm's record-keeping and investigation procedures for critical biological products.