FDA 483 - New York Presbyterian Hospital Services - September 10, 2025

An FDA inspection of NewYork-Presbyterian/Weill Cornell Medical Center in New York identified significant deficiencies in their blood bank operations. The facility failed to consistently follow written standard operating procedures for the distribution of blood and blood components, including issues with visual inspections and accurate record-keeping for mass hemorrhage protocols. Additionally, the firm did not maintain adequate processing, quality control, and general records, with specific concerns regarding documentation for reconstituted whole blood, temperature monitoring, reagent preparation, and investigation of testing discrepancies.