FDA 483 - Elmhurst Hospital Center - February 01, 2019

An FDA inspection of Elmhurst Hospital Center's Blood Bank revealed significant deficiencies in maintaining and following written standard operating procedures for the processing, storage, and distribution of blood and blood components. The facility also failed to maintain adequate processing, quality control, and general records, particularly concerning platelet units and pH meter calibration. These issues indicate a lack of robust control over critical blood bank operations.