FDA 483 - Cumberland County Hospital System, Inc. - January 07, 2025

An FDA inspection of Cumberland County Hospital System, Inc.'s Donor Center in Fayetteville, NC, revealed a significant issue regarding the documentation of donor adverse reactions. The facility failed to prepare and maintain written reports of investigations for all adverse reactions, specifically not recording minor or other reactions in their donor management system or on reaction forms. Only moderate or severe reactions were being captured, indicating a systemic failure in adverse event reporting and record-keeping.