FDA 483 - Geisinger Medical Center Blood Bank - January 24, 2019

An FDA inspection of Geisinger Medical Center's Hospital Blood Bank in Danville, PA, revealed significant deficiencies in record-keeping and equipment calibration. The facility failed to thoroughly investigate biological product deviations and maintain complete records for emergency blood product releases. Additionally, annual calibration records for critical storage equipment were missing, indicating a lack of control over blood and blood component handling.