483
Geisinger Medical Center Blood BankGeisinger Medical Center Blood Bank – FDA 483, Jan 24, 2019
Record Details
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.
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