FDA 483 - Lee Memorial Health System - August 06, 2021

Lee Memorial Health System, a blood bank in Fort Myers, FL, was inspected and cited for multiple deficiencies related to donor notification and record-keeping. The inspection revealed failures in attempting to notify deferred donors, documenting notification attempts, and ensuring standard operating procedures adequately describe the notification process. Additionally, the firm failed to include required content in donor notification letters and did not consistently obtain valid contact addresses from donors.