FDA 483 - North Shore University Hospital Northwell Health - April 26, 2023

North Shore University Hospital Northwell Health, a blood bank in Manhasset, NY, was inspected by the FDA and received a Form 483 with three observations. The inspection revealed failures in submitting biological deviation reports, not consistently following written standard operating procedures for blood product handling, and inadequate maintenance of quality control and general records for analyzer operating conditions. These issues indicate deficiencies in quality system controls and record-keeping practices.