FDA 483 - Arnot Ogden Medical Center - August 14, 2019

An FDA inspection of Arnot Ogden Medical Center's Hospital Blood Bank revealed significant deficiencies in their quality system. Observations included a lack of written standard operating procedures for investigating product deviations, inadequate equipment maintenance and calibration practices, and incomplete records for transfusion reaction investigations. These issues indicate a need for improved adherence to regulatory requirements for blood and blood component processing.