FDA 483 - Long Island Jewish Medical Center - March 15, 2024

An FDA inspection of Long Island Jewish Medical Center's blood bank identified three observations related to record-keeping and adherence to standard operating procedures. Issues included inaccurate documentation of personnel performing tests and preparation times for blood products, as well as failures in maintaining irradiator malfunction logs. Additionally, the facility did not consistently follow procedures for the visual inspection of blood products prior to issuance for transfusion.